A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Latest Information Update: 02 Jan 2023
At a glance
- Drugs Fostamatinib (Primary)
- Indications Idiopathic thrombocytopenic purpura
- Focus Registrational; Therapeutic Use
- Acronyms FIT2
- Sponsors Rigel Pharmaceuticals
- 23 Dec 2022 According to a Kissei Pharmaceutical media release, based on the results of the Phase 3 clinical trials of TAVALISSE in ITP patients in Japan and outside of Japan, the Ministry of Health, Labour and Welfare (MHLW) has granted manufacturing and marketing approval for the oral spleen tyrosine kinase inhibitor, TAVALISSE (Tab. 100mg and 150mg (generic name: fostamatinib disodium hexahydrate)), for chronic idiopathic thrombocytopenic purpura (chronic ITP).
- 14 Jul 2021 Post hoc analysis of the FIT Phase 3 program published in the Rigel Pharmaceuticals Media Release.
- 14 Jul 2021 According to a Rigel Pharmaceuticals media release, post hoc analysis of the FIT Phase 3 program will be presented at the upcoming International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress.
Most Recent Events
Trial Overview
Purpose
This phase III study is designed to investigate the efficacy and safety of fostamatinib, in patients with persistent or chronic immune thrombocytopenic purpura.
Comments
According to a Grifols media release, European Commission has approved TAVLESSE (fostamatinib) for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.
Based on the data from the Phase 3 clinical program [Study 047, 048 and 049] the U.S. FDA approved TAVALISSE (fostamatinib disodium) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia. Together with an initial proof of concept study, the NDA included 163 ITP patients (as of 17th Apr 2018).
According to a Kissei Pharmaceutical media release, based on the results of the Phase 3 clinical trials of TAVALISSE in ITP patients in Japan and outside of Japan, the Ministry of Health, Labour and Welfare (MHLW) has granted manufacturing and marketing approval for the oral spleen tyrosine kinase inhibitor, TAVALISSE (Tab. 100mg and 150mg (generic name: fostamatinib disodium hexahydrate)), for chronic idiopathic thrombocytopenic purpura (chronic ITP).
Primary Endpoints
Stable platelet response of at least 50,000/µL
description: Stable platelet response by Week 24 defined as a platelet count of at least 50,000/µL on at least 4 of the 6 visits between Weeks 14-24
time_frame: Baseline to Week 24
Other Endpoints
Number of Participants With Platelet Count ≥ 50,000/µL at Week 12
description: Platelet Count ≥ 50,000/µL at Week 12 time_frame: Baseline to Week 12
Number of Participants With Platelet Count ≥ 50,000/µL at Week 24
description: Platelet Count ≥ 50,000/µL at Week 24 time_frame: Baseline to Week 24
Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 12
description: Among subjects with a baseline platelet count < 15,000/μL, achievement of a count ≥ 30,000/μL and at least 20,000/μL above baseline at Week 12. time_frame: Baseline to Week 12
Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 24
description: Among subjects with a baseline platelet count < 15,000/μL, achievement of a count ≥ 30,000/μL and at least 20,000/μL above baseline at Week 24 time_frame: Baseline to Week 24
Frequency and Severity of Bleeding According to the ITP Bleeding Score (IBLS)
description: The ITP Bleeding Scale (IBLS) is an immune thrombocytopenic purpura (ITP)-specific bleeding score used to analyze the correlation of clinical and laboratory platelet variables with bleeding. The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage. After each grade is scored, the mean value for all 11 grades is calculated (lowest score being 0 and highest score being 2) for each subject visit. LOCF method was used to impute any missing data. The mean of the IBLS scores across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint. time_frame: Baseline to Week 24
Frequency and Severity of Bleeding According to the World Health Organization (WHO) Bleeding Scale
description: The World Health Organization (WHO) bleeding scale is a standardized grading scale created to measure the severity of bleeding. The scale is a clinical investigator-assessed five-point scale with a score range starting at the lowest 0=No bleeding, 1 = Petechiae, 2=Mild blood loss, 3=Gross blood loss, to the worse 4=Debilitating blood loss. The WHO bleeding scale is scored by history over the previous-week or by exam. After each grade is scored, the mean value is calculated (lowest score being 0 [no bleeding] to the highest score being 4 [debilitating blood loss]) for each visit. LOCF method was used to impute any missing data. The mean of the WHO bleeding scale across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint. time_frame: Baseline to Week 24 [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
Idiopathic thrombocytopenic purpura | treatment | - |
Subjects
- Subject Type patients
-
Number
Planned: 75
Actual: 74
- Sex male & female
- Age Group ≥ 18 years; adult; elderly
Patient Inclusion Criteria
1.Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures.
2.Subject must have had a diagnosis of ITP for at least 3 months and no known etiology for thrombocytopenia.
3.Subject's platelet count averages < 30,000/µL (and none > 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts within the preceding 3 months. At least 2 of the qualifying counts must have been taken during the screening period.
4.Must have previously received at least 1 typical regimen for the treatment of ITP.
5.Male or female at least 18 years of age.
6.Performance status on Karnofsky performance status scale (KPS) > 70
7.Subject's concurrent treatment for ITP may consist of either glucocorticoids (< 20 mg prednisone equivalent per day), or azathioprine or danazol. The dose of the concurrent medication must have been stable for 14 days prior to baseline and must be expected to remain stable throughout the study. No other concurrent medications for ITP are permitted.
8.Subject's other therapeutic agents for ITP have been discontinued in accordance with the washout periods
9.Female subject must be either post-menopausal for at least 1 year or surgically sterile; or if female of child-bearing potential, must not be pregnant or lactating and must agree to use an acceptable method of birth control throughout the duration of the trial and for 30 days following the last dose. Acceptable methods of birth control are defined as: hormonal contraception (pill, injection or implant) used consistently for at least 30 days prior to screening, an intrauterine device (IUD), a double-barrier method (ie, condom and spermicide, or condom and diaphragm), or complete abstinence.
10.In the Investigator's opinion, the subject has the ability to understand the nature of the study and any hazards of participation and to communicate satisfactorily with the Investigator.
Patient Exclusion Criteria
1.Subject with ITP associated with lymphoma, chronic lymphocytic leukemia, viral infection, autoimmune disorders, thyroid disease, human immunodeficiency virus, or hepatitis or induced or alloimmune thrombocytopenia, or thrombocytopenia associated with myeloid dysplasia.
2.Subject with autoimmune hemolytic anemia.
3.Subject has a history of or active, clinically significant, respiratory, gastrointestinal (pancreatitis), renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorders that, in the Investigator's opinion, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug.
4.Subject has had any major cardiovascular event within the 6 months prior to randomization, including but not limited to; myocardial infarction, unstable angina, cerebrovascular accident, pulmonary embolism, or New York Heart Association Class III or IV heart failure.
5.Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 140 mm Hg, or diastolic blood pressure ≥ 90 mm Hg, whether or not the subject is receiving anti-hypertensive treatment. Subjects may be rescreened if the blood pressure is successfully and promptly controlled (within 30 days) using conventional anti-hypertensive therapy to achieve optimal blood pressure control (< 140/90 mmHg).
6.Subject has a history of coagulopathy including prothrombotic conditions such as Factor V Leiden, APC resistance, AT-III deficiency and lupus anticoagulant, or arterial or deep venous thrombosis within 6 months prior to randomization.
7.In subjects with deep venous thrombosis greater than 6 months prior to randomization, anticoagulants must have been discontinued for at least 30 days and subsequent D dimer must be within normal limits for the site's local laboratory.
8.Subject has a bleeding assessment score of Grade 2 at any site by the ITP Bleeding Scale (IBLS).
9.Subject has 1 or more of the following laboratory abnormalities: leukocyte count < 2,500/µL, neutrophil count of < 1,500/µL, lymphocyte count < 750/µL, Hgb < 10 g/L without ongoing transfusion support, or transaminase levels (ALT, AST) > 1.5x ULN, total bilirubin > 2.0 mg/dL, or estimated glomerular filtration rate (eGFR) < 30 mL/min at the time of screening and/or baseline (Day 1).
10.Subject has a significant infection, or an acute infection such as influenza, or is known to have an active inflammatory process at the time of screening and/or baseline (Day 1).
11.Subject has acute gastrointestinal symptoms at the time of screening and/or baseline (eg, nausea, vomiting, diarrhea, abdominal pain).
12.Subject has increased the dose of, or added, prescription drugs within the 2 weeks prior to Day 1, unless agent is agreed to be not clinically relevant by both the Investigator and Sponsor.
13.Subject has had positive results for HIV, HBV, or HCV by standard serologic tests.
14.Subject has received any blood or blood products within the 2 weeks prior to randomization. (IVIg or anti-rho (D) immunoglobulin (anti-D) are allowed if used for rescue therapy, unless platelet count is > 30,000/µL at the time of randomization.)
15.Subject is currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or 5 half-lives (whichever is longer) of Day 1.
16.Subject has a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.
17.Subject has a known allergy and/or sensitivity to the test article or its components.
Trial Details
Identifiers
Identifier | Owner |
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NCT02076412 | ClinicalTrials.gov: US National Institutes of Health |
EudraCT2013-005453-76 | European Clinical Trials Database |
16385 | United Kingdom Clinical Research Network |
C935788-048 | - |
CCRN3064 | - |
Organisations
- Sponsors Rigel Pharmaceuticals
- Affiliations Kissei Pharmaceutical; Rigel Pharmaceuticals
Trial Dates
-
Initiation Dates
Planned : 01 Jun 2014
Actual : 01 Nov 2014
-
Primary Completion Dates
Planned : 01 Sep 2016
Actual : 01 Aug 2016
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End Dates
Planned : 01 Sep 2016
Actual : 01 Aug 2016
Substudies/Extensions
Patients have the option to enrol in an extension study.
Other Details
- Design double-blind; multicentre; parallel; prospective; randomised
- Phase of Trial Phase III
- Location Austria; Bulgaria; Czech Republic; England; Germany; Norway; Poland; Romania; Spain; USA
- Focus Registrational; Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
FostamatinibPrimary Drug | Oral | Tablet |
Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks. Drug: Fostamatinib Disodium (Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.) Other Name: R935788, R788, Fostamatinib
Placebo
Placebo tablet PO bid (morning and evening) over the course of 24 weeks Drug: Placebo (Placebo tablet PO bid (morning and evening))
Results
Therapeutic efficacy
Data from the FIT phase III trials (047, 048 and 049 studies) demonstrated that fostamatinib was effective for certain immune thrombocytopenic purpura patients. Additionally, the benefit was consistent across all sub-groups analysed including TPO (blood platelet production booster) experienced patients who had limited treatment options remaining [2] .
In the pooled analysis from the phase III 047 and 048 studies, stable response was reported in 18 and transient response was reported in 11 of the 101 treated patients, compared with only one stable response and no transient responses in patients receiving placebo (n = 49). The overall response rate was 29% (29/101) in fostamatinib arm and 2% (1/49) in placebo arm (p = < 0.0001) [3] .
Adverse events
Phase III: Mild or moderate adverse events (AEs), with gastrointestinal related AEs were observed most frequently, and were reversible over time. No new or unusual safety issues were reported in the randomised, double-blind, phase III FIT 1 and FIT 2 trials evaluating fostamatinib versus placebo in patients with persistent or chronic ITP [4] [5] .
Publications
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Rigel Pharmaceuticals. Fostamatinib Study Results Continue to Trend Positive. Media-Rel 2017;.
Media Release -
Cooper N, Ghanima W, Hill Q, Boccia R, Flynn R, Numerof RP, et al. Second-Line Therapy for Immune Thrombocytopenia with the Spleen Tyrosine Kinase Inhibitor Fostamatinib. EHA-2020 2020; abstr. EP1625.
Available from: URL: http://link.adisinsight.com/j8A6P -
Bussel J, Arnold DM, Grossbard E, Mayer J, Trelinski J, Homenda W, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: Results of two phase 3, randomized, placebo-controlled trials. Am-J-Hematol 2018;93(7):921-930.
PubMed | CrossRef Fulltext -
Boccia R, Boxer MA, Ghanima W, Hill QA, Sholzberg M, Tarantino MD, et al. Enhanced Responses to Fostamatinib As Second-Line Therapy and in Persistent Immune Thrombocytopenia (ITP) Patients. ASH-Hem-2019 2019; abstr. 1069.
Available from: URL: https://ash.confex.com/ash/2019/webprogram/Paper126473.html -
Boccia R, Cooper N, Ghanima W, Boxer MA, Hill QA, Sholzberg M, et al. Fostamatinib is an effective second-line therapy in patients with immune thrombocytopenia. Br-J-Haematol 2020;190(6):933-938.
PubMed | CrossRef Fulltext -
Bussel JB, Arnold D, Cooper N, Abdallah A, Boxer M, Liles DK, et al. Two placebo-controlled phase 3 studies of fostamatinib, an oral spleen tyrosine kinase (Syk) inhibitor, for the treatment of persistent/chronic immune thrombocytopenia (ITP) in adults: Analysis of platelet response by prior ITP therapies. ASCO-2018 2018; abstr. e15146.
Available from: URL: http://abstracts.asco.org/214/AbstView_214_228591.html -
Bussel J, Arnold D, Boccia R, Boxer M, Cooper N, Hill Q, et al. Long-Term Fostamatinib Treatment of Adults with Immune Thrombocytopenia (Itp) During the Phase 3 Clinical Trial Program. EHA-2019 2019; abstr. PF703.
Available from: URL: https://library.ehaweb.org/eha/2019/24th/266502/j.bussel.long-term.fostamatinib.treatment.of.adults.with.immune.html?f=listing%3D3%2Abrowseby%3D8%2Asortby%3D2%2Amedia%3D3%2Ace_id%3D1550 -
Bussel JB, Arnold DM, Boxer MA, Cooper N, Mayer J, Zayed H, et al. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am-J-Hematol 2019;94(5):546-553.
PubMed | CrossRef Fulltext -
Rigel Pharmaceuticals. New TAVALISSE(Rm) Data Analyses To Be Presented at International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress. Media-Rel 2021;.
Media Release
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
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Alexander Röth, MD | Universittsklinikum Essen | Germany |
Alois Lang, MD
43 (0)5522 303 2301
show details
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LKH Feldkirch at LKH Rankweil | Austria |
Andrei Colita, MD
+40722661228
show details
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Spitalul Clinic Coltea, Hematologie | Romania |
Andrzej Hellmann, MD
4858 349 22 30
show details
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Uniwersyteckie Centrum Kliniczne | Poland |
Aristoteles Giagounidis, MD
211 44002501
show details
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Marien Hospital Duesseldorf | Germany |
Axel Nogai, MD
1 30 00 450 513537
show details
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Charit Berlin - Campus Benjamin Franklin | Germany |
Bjorn Gjertsen, MD
47 55972890
show details
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Haukeland University Hospital | Norway |
Bradley Cohen, MD
845-362-1750
show details
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Hematology Oncology Associates of Rockland Division of Highland Medical PC | USA |
Dariusz Woszczyk, MD
+48 606 625 611
show details
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Szpital Wojewodzki w Opolu | Poland |
David Valcarcel, MD
34 932746100
show details
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Hospital Universitari Vall D'Hebron | Spain |
Elisa Orna Montero, MD
34 93 497 88 68
show details
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Hospital Universitari Germans Trias i Pujol | Spain |
Evgueniy Hadjiev, MD
+ 359 29230588
show details
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UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology | Bulgaria |
Galafteon Oltean, MD
+40722771065
show details
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Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie | Romania |
Ingrid Pabinger-Fasching, MD
+431 40400 2757
show details
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Medizinische Universitaet Wien / AKH Wien | Austria |
Isidro Jarque Ramos, MD
34 961245876
show details
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Hospital Universitari i Politécnic La Fe de Valencia | Spain |
Jaromir Gumulec, MD
420 734648047
show details
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Fakultni nemocnice Ostrava | Czech-Republic |
Jerzy Windyga, MD
48 22 34 96 157
show details
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Instytut Hematologii I Transfuzjologii | Poland |
Jiří Mayer, MD | Fakultni nemocnice Brno | Czech-Republic |
Krzysztof Giannopoulos, MD
+4881 5345468
show details
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Specjalistyczny Gabinet Lekarski | Poland |
Liliya Sivcheva, MD
+359 92625561
show details
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MHAT Hristo Botev, AD, Vratsa, First Internal Department | Bulgaria |
Lowe A
Phone: 1.512-502-5353
show details
alowe@rigel.com |
Rigel Pharmaceuticals |
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Marek Trneny, MD
22496 2527
show details
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Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie | Czech-Republic |
Maria Podolak-Dawidziak, MD
+74817 842576
show details
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Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw | Poland |
Maria Teresa Alvarez Roman, MD
34 917277225
show details
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Hospital Universitariola Paz | Spain |
Mario von Depka Prondzinski, MD
49 51133059911
show details
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Werlhof Institut GmbH | Germany |
Mathias Rummel, MD
641 985 42650
show details
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Universitaetsklinikum Giessen und Marburg (UKGM) | Germany |
Michael Fillitz, MD
+43 1 91021 85440
show details
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Hanusch-Krankenhaus Wiener Gebietskrankenkasse | Austria |
Nikolay Tzvetkov, MD
359 64 886335
show details
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UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology | Bulgaria |
Olga Cerna, MD
+420 267 16 2887
show details
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Fakultni nemocnice Kralovske Vinohrady | Czech-Republic |
Petr Svoboda, MD, PhD
+359 602 514303
show details
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Hospital Kyjov | Czech-Republic |
Rigel Pharmaceuticals, Inc.
clinicaltrials@rigel.com
show details
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Rigel Pharmaceuticals, Inc. |
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Tadeusz Robak, MD
+4842 689 5191
show details
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Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi | Poland |
Toshko J Lissitchkov, MD, PhD, DSc
+359 2 9701 235
show details
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Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology; | Bulgaria |
Viola Maria Popov, MD
40745185053
show details
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Spitalul Clinic Colentina, Hematologie | Romania |
Waleed Ghanima, MD
+4769860000
show details
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Sykehuset Østfold Fredrikstad | Norway |
Wojciech Homenda, MD
4859 846 03 50
show details
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Wojewodzki Szpital Specjalistyczny im. J. Korczaka | Poland |
Zbigniew Walter, MD
4812 4247620
show details
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Szpital Uniwersytecki | Poland |
Centres
Centre Name | Location | Trial Centre Country |
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Charit Berlin - Campus Benjamin Franklin | Berlin | Germany |
Fakultni nemocnice Brno | Brno, CZ | Czech-Republic |
Fakultni nemocnice Kralovske Vinohrady | Praha 10 | Czech-Republic |
Fakultni nemocnice Ostrava | Ostrava-Poruba | Czech-Republic |
Hanusch-Krankenhaus Wiener Gebietskrankenkasse | Vienna, AU | Austria |
Haukeland University Hospital | Bergen | Norway |
Hematology Oncology Associates of Rockland Division of Highland Medical PC | Nyack, New York | USA |
Hospital Kyjov | Kyjov, CZ | Czech-Republic |
Hospital Universitari Germans Trias i Pujol | Barcelona | Spain |
Hospital Universitari i Politécnic La Fe de Valencia | Valencia | Spain |
Hospital Universitari Vall D'Hebron | Barcelona | Spain |
Hospital Universitariola Paz | Madrid | Spain |
Instytut Hematologii I Transfuzjologii | Warszawa | Poland |
LKH Feldkirch at LKH Rankweil | Rankweil | Austria |
Marien Hospital Duesseldorf | Duesseldorf | Germany |
Medizinische Universitaet Wien / AKH Wien | Wien, AU | Austria |
MHAT Hristo Botev, AD, Vratsa, First Internal Department | Vratsa, BG | Bulgaria |
Rigel Pharmaceuticals
clinicaltrials@rigel.com
show details
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Rigel Pharmaceuticals, Inc. |
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Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw | Wroclaw | Poland |
Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology; | Sofia, BG | Bulgaria |
Specjalistyczny Gabinet Lekarski | Lublin | Poland |
Spitalul Clinic Colentina, Hematologie | Bucuresti | Romania |
Spitalul Clinic Coltea, Hematologie | Bucuresti | Romania |
Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie | Targu Mures, Mures | Romania |
Sykehuset Østfold Fredrikstad | Fredrikstad | Norway |
Szpital Uniwersytecki | Krakow | Poland |
Szpital Wojewodzki w Opolu | Opole | Poland |
UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology | Sofia | Bulgaria |
UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology | Pleven | Bulgaria |
Universitaetsklinikum Giessen und Marburg (UKGM) | Giessen, DE | Germany |
Universittsklinikum Essen | Essen | Germany |
Uniwersyteckie Centrum Kliniczne | Gdansk | Poland |
Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie | Praha 2 | Czech-Republic |
Werlhof Institut GmbH | Hannover, DE | Germany |
Wojewodzki Szpital Specjalistyczny im. J. Korczaka | Slupsk | Poland |
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi | Lodz | Poland |
Trial History
Event Date | Event Type | Comment |
---|---|---|
23 Dec 2022 | Other trial event | According to a Kissei Pharmaceutical media release, based on the results of the Phase 3 clinical trials of TAVALISSE in ITP patients in Japan and outside of Japan, the Ministry of Health, Labour and Welfare (MHLW) has granted manufacturing and marketing approval for the oral spleen tyrosine kinase inhibitor, TAVALISSE (Tab. 100mg and 150mg (generic name: fostamatinib disodium hexahydrate)), for chronic idiopathic thrombocytopenic purpura (chronic ITP). Updated 02 Jan 2023 |
14 Jul 2021 | Results | Post hoc analysis of the FIT Phase 3 program published in the Rigel Pharmaceuticals Media Release. Updated 16 Jul 2021 |
14 Jul 2021 | Other trial event | According to a Rigel Pharmaceuticals media release, post hoc analysis of the FIT Phase 3 program will be presented at the upcoming International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress. Updated 16 Jul 2021 |
01 Sep 2020 | Results | Results of a post hoc analysis comparing patients who received Fostamatinib as second line therapy versus third or greater line therapy (a data from FIT-1, FIT-2 and OLE FIT-3 studies) published in the British Journal of Haematology Updated 24 Mar 2021 |
27 Jul 2020 | Other trial event | According to a Rigel Pharmaceuticals media release, post hoc analysis of the data of this study were published in the British Journal of Haematology. Updated 30 Jul 2020 |
21 Jun 2020 | Results | Results (N=145), of post hoc analysis of data from 3 phase III studies assessing the response in patients for whom Fostamatinib was second-line or greater line therapy, presented at the 25th Congress of the European Haematology Association Updated 20 Jul 2020 |
16 Jan 2020 | Other trial event | According to a Grifols media release, European Commission has approved TAVLESSE (fostamatinib) for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. Updated 17 Jan 2020 |
10 Dec 2019 | Results | Results of post hoc analysis of the three phase 3 clinical studies (two randomized, controlled trials and 1 open-label extension study) has presented at the 61st Annual Meeting and Exposition of the American Society of Hematology. Updated 13 Dec 2019 |
15 Nov 2019 | Other trial event | According to a Rigel Pharmaceuticals media release, the CHMP based its opinion on data provided from the FIT Phase 3 clinical program, which included two randomized placebo-controlled trials (FIT1 and FIT2) and an open-label extension trial (FIT3). The MAA included data from 163 ITP patients and was supported by a safety database of more than 4,600 subjects across all other indications in which fostamatinib has been evaluated. Updated 22 Nov 2019 |
15 Nov 2019 | Other trial event | According to a Rigel Pharmaceuticals media release, the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency, has adopted a positive opinion for Rigels Marketing Authorization Application (MAA) for fostamatinib disodium hexahydrate (fostamatinib) for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments. Updated 22 Nov 2019 |
16 Jun 2019 | Results | Results of polled post hoc analysis from FIT phase III program including an open-label extension phase (n=146) presented at the 24th Congress of the European Haematology Association. Updated 30 Aug 2019 |
01 May 2019 | Results | Results assessing long-term fostamatinib treatment by using data from two RCTs and an open label study published in the American Journal of Hematology. Updated 14 Feb 2020 |
01 Feb 2019 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 01 Feb 2019 |
01 Jul 2018 | Results | Results of two studies (FIT1 and FIT2) assessing efficacy and safety of fostamatinib for the treatment of persitent/chronic immune thrombocytopenia purpura, published in the American Journal of Hematology. Updated 23 Jul 2019 |
05 Jun 2018 | Results | Results of a pooled analysis of NCT02076399 and NCT02076412 assessing responses by prior therapy and baseline platelet count, presented at the 54th Annual Meeting of the American Society of Clinical Oncology Updated 19 Jun 2018 |
30 Apr 2018 | Other trial event | According to a Rigel Pharmaceuticals media release, data from this trial has been published in American Journal of Hematology. Updated 07 May 2018 |
17 Apr 2018 | Other trial event | According to a Rigel Pharmaceuticals media release, based on the data from the Phase 3 clinical program [Study 047, 048 and 049] the U.S. FDA has approved TAVALISSE (fostamatinib disodium) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia. Together with an initial proof of concept study, the NDA included 163 ITP patients. Updated 07 Jun 2018 |
22 Jun 2017 | Other trial event | According to a Rigel Pharmaceuticals media release, data will be presented at the European Hematology Association 22nd Annual Congress (EHA). Updated 29 Jun 2017 |
19 Jun 2017 | Other trial event | According to a Rigel Pharmaceuticals media release, based on the data from the Phase 3 clinical program [Study 047, 048 and 049] the U.S. FDA has accepted New Drug Application for the use of TAVALISSE (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia. Together with an initial proof of concept study, the NDA included 163 ITP patients. The company expects the action date for the FDA to complete its review will be April 17, 2018, under the PDUFA. Updated 27 Jun 2017 |
17 Apr 2017 | Other trial event | According to a Rigel Pharmaceuticals media release, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fostamatinib in patients with chronic and persistent immune thrombocytopenia (ITP), NDA is supported by data from the Phase 3 clinical program [Study 047, 048 and 049] Updated 19 Apr 2017 |
07 Mar 2017 | Other trial event | According to a company media release, Rigel believes that the data from the FIT Phase 3 clinical program support its intention to submit a New Drug Application (NDA) for fostamatinib in immune thrombocytopenia to the US Food and Drug Administration (FDA) in March 2017. Updated 10 Mar 2017 |
30 Jan 2017 | Results | Results published in the Rigel Pharmaceuticals Media Release Updated 03 Feb 2017 |
05 Jan 2017 | Other trial event | According to a Rigel Pharmaceuticals media release, data from this trial will be highlighted in presentation at the 35th Annual J.P. Morgan Healthcare Conference 2017. Updated 09 Jan 2017 |
30 Nov 2016 | Other trial event | Last checked against European Clinical Trials Database record. Updated 30 Nov 2016 |
15 Nov 2016 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 22 Nov 2016 |
20 Oct 2016 | Other trial event | According to Rigel Pharmaceutical's media release, results will be presented in a webcast. Updated 07 Nov 2016 |
20 Oct 2016 | Results | Results published in the Rigel Pharmaceutical's Media Release. Updated 07 Nov 2016 |
20 Oct 2016 | Other trial event | This trial has been completed in Bulgaria (end date: 31 Aug 2016) Updated 20 Oct 2016 |
12 Oct 2016 | Other trial event | This trialwas completed in Czech Republic (end date: 2016-08-31), according to European Clinical Trials Database. Updated 13 Oct 2016 |
02 Oct 2016 | Other trial event | This trial has been completed in Spain (End date:2016-08-31) as per European Clinical Trials Database record. Updated 05 Oct 2016 |
01 Oct 2016 | Other trial event | This trial has been completed in Austria (End date:2016-08-31) as per European Clinical Trials Database record. Updated 05 Oct 2016 |
30 Aug 2016 | Other trial event | According to a Rigel Pharmaceuticals media release, the company expects to submit a New Drug Application with the U.S. Food and Drug Administration in the first quarter of 2017. Updated 19 Sep 2016 |
30 Aug 2016 | Other trial event | According to a Rigel Pharmaceuticals media release, results from this study are expected in October/November 2016 and will be presented at future medical meetings. Updated 19 Sep 2016 |
29 Jul 2016 | Completion date | Planned End Date changed from 1 Jun 2016 to 1 Sep 2016. Updated 04 Aug 2016 |
29 Jul 2016 | Other trial event | Planned primary completion date changed from 1 Jun 2016 to 1 Sep 2016. Updated 04 Aug 2016 |
08 Jun 2016 | Other trial event | Last checked against UK Clinical Trials Register record. Updated 08 Jun 2016 |
03 May 2016 | Other trial event | According to Rigel Pharmaceuticals media release, the results of this study are expected shortly after middle 2016. Updated 05 May 2016 |
01 Apr 2016 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting, as per Rigel media release. Updated 05 Apr 2016 |
16 Nov 2015 | Completion date | Planned End Date changed from 1 Oct 2016 to 1 Jun 2016 as reported by ClinicalTrials.gov. Updated 10 Dec 2015 |
16 Nov 2015 | Other trial event | Planned primary completion date changed from 1 Oct 2016 to 1 Jun 2016 as reported by ClinicalTrials.gov. Updated 10 Dec 2015 |
13 Nov 2015 | Completion date | Planned End Date changed from 1 Oct 2015 to 1 Oct 2016 as reported by ClinicalTrials.gov record. Updated 21 Nov 2015 |
13 Nov 2015 | Other trial event | Planned primary completion date changed from 1 Oct 2015 to 1 Oct 2016 as reported by ClinicalTrials.gov record. Updated 21 Nov 2015 |
08 Sep 2015 | Other trial event | According to a Rigel Pharmaceuticals media release, this study has surpassed the half-way point in enrolment. Updated 10 Sep 2015 |
07 May 2015 | Other trial event | According to a company media release, Rigel expects to file the U.S New Drug Application (NDA) for fostamatinib in ITP by the end of 2016 based on the data of this and one other study. Updated 08 May 2015 |
07 May 2015 | Other trial event | According to a Rigel Pharmaceuticals media release, top-line data from this study is expected in mid-2016. Updated 08 May 2015 |
06 Apr 2015 | Other trial event | New source identified and integrated (United Kingdom Clinical Research Network; 16385) Updated 06 Apr 2015 |
31 Dec 2014 | Protocol amendment | Treatment have been changed to 100 mg bid and 150 mg bid according to ClinicalTrials.gov. Updated 31 Dec 2014 |
04 Nov 2014 | Other trial event | According to a Rigel Pharmaceuticals media release, topline data from this study is expected in the Q1 2016. Updated 03 Jul 2015 |
19 Aug 2014 | Other trial event | New source integrated (European Clinical Trials Database: EudraCT2013-005453-76). Updated 19 Aug 2014 |
13 Aug 2014 | Other trial event | This study was recently initiated, according to a Rigel Pharmaceuticals media release. Updated 13 Oct 2014 |
13 Aug 2014 | Status change - recruiting | Status changed from not yet recruiting to recruiting, according to a Rigel Pharmaceuticals media release. Updated 13 Oct 2014 |
10 Mar 2014 | New trial record | New trial record Updated 10 Mar 2014 |
24 Oct 2013 | Other trial event | Trial initiation is expected in the first half of 2014 and top-line data in 2015, according to a Rigel Pharmaceuticals media release. Updated 13 Mar 2014 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Rigel Pharmaceuticals. Rigel Announces Fourth Quarter 2016 and Year End 2016 Financial Results and Provides Company Update. Media-Rel 2017;.
Media Release -
Rigel Pharmaceuticals. Fostamatinib Study Results Continue to Trend Positive. Media-Rel 2017;.
Media Release -
Rigel Pharmaceuticals. Rigel Announces Results from the Second FIT Phase 3 Study and the Long-Term Open-Label Extension Study for Fostamatinib in ITP. Media-Rel 2016;.
Media Release -
Rigel Pharmaceuticals. Rigel's Fostamatinib Meets Primary Endpoint in Phase 3 Study in Chronic ITP. Media-Rel 2016;.
Media Release -
Rigel Pharmaceuticals Inc. Rigel Provides Pipeline Update. Media-Rel 2013;.
Media Release -
Cooper N, Ghanima W, Hill Q, Boccia R, Flynn R, Numerof RP, et al. Second-Line Therapy for Immune Thrombocytopenia with the Spleen Tyrosine Kinase Inhibitor Fostamatinib. EHA-2020 2020; abstr. EP1625.
Available from: URL: http://link.adisinsight.com/j8A6P -
Rigel Pharmaceuticals. Rigel Completes Enrollment of FIT Phase 3 Program for Fostamatinib in ITP. Media-Rel 2016;.
Media Release -
Rigel Pharmaceuticals. Rigel Announces FDA Approval of TAVALISSE(Tm) (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia (ITP) in Adult Patients. Media-Rel 2018;.
Media Release -
Rigel Pharmaceuticals. Rigel Announces First Quarter 2015 Financial Results. Media-Rel 2015;.
Media Release -
Rigel Pharmaceuticals. Rigel Provides Business Updates and Preliminary Data in IgA Nephropathy. Media-Rel 2017;.
Media Release -
Bussel J, Arnold DM, Grossbard E, Mayer J, Trelinski J, Homenda W, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: Results of two phase 3, randomized, placebo-controlled trials. Am-J-Hematol 2018;93(7):921-930.
PubMed | CrossRef Fulltext -
United Kingdom Clinical Research Network. Trial-Reg 2016;.
Available from: URL: http://www.ukcrn.org.uk -
Rigel Pharmaceuticals. TAVALISSE(TM) (fostamatinib disodium hexahydrate) Phase 3 Data Published in the American Journal of Hematology Describes Pivotal Data and Overall Response Rate Versus Placebo. Media-Rel 2018;.
Media Release -
European Clinical Trials Database. Trial-Reg 2023;.
Available from: URL: https://www.clinicaltrialsregister.eu -
Rigel Pharmaceuticals. Rigel Announces Oral Presentation of TAVALISSE(T) (fostamatinib disodium) Phase 3 Clinical Data at the European Hematology Association 22nd Annual Congress. Media-Rel 2017;.
Media Release -
Boccia R, Boxer MA, Ghanima W, Hill QA, Sholzberg M, Tarantino MD, et al. Enhanced Responses to Fostamatinib As Second-Line Therapy and in Persistent Immune Thrombocytopenia (ITP) Patients. ASH-Hem-2019 2019; abstr. 1069.
Available from: URL: https://ash.confex.com/ash/2019/webprogram/Paper126473.html -
Boccia R, Cooper N, Ghanima W, Boxer MA, Hill QA, Sholzberg M, et al. Fostamatinib is an effective second-line therapy in patients with immune thrombocytopenia. Br-J-Haematol 2020;190(6):933-938.
PubMed | CrossRef Fulltext -
Rigel Pharmaceuticals. Marketing Authorization Approval in Japan for TAVALISSE(R) Tab. 100mg and 150mg, an Oral Spleen Tyrosine Kinase Inhibitor. Media-Rel 2022;.
Media Release -
Rigel Pharmaceuticals. FDA Accepts Rigel's New Drug Application for TAVALISSE(T) (fostamatinib disodium) for the Treatment of Chronic ITP. Media-Rel 2017;.
Media Release -
Bussel JB, Arnold D, Cooper N, Abdallah A, Boxer M, Liles DK, et al. Two placebo-controlled phase 3 studies of fostamatinib, an oral spleen tyrosine kinase (Syk) inhibitor, for the treatment of persistent/chronic immune thrombocytopenia (ITP) in adults: Analysis of platelet response by prior ITP therapies. ASCO-2018 2018; abstr. e15146.
Available from: URL: http://abstracts.asco.org/214/AbstView_214_228591.html -
Rigel Pharmaceuticals. Rigel Announces Third Quarter 2014 Financial Results. Media-Rel 2014;.
Media Release -
Rigel Pharmaceuticals. R348 Did Not Meet Endpoints in Phase 2 Dry Eye Study. Media-Rel 2014;.
Media Release -
Grifols. Grifols to launch TAVLESSE(R) in Europe and Turkey to continue reinforcing its commercial strategy and commitment to patients. Media-Rel 2020;.
Media Release -
Rigel Pharmaceuticals. Rigel Receives Positive CHMP Opinion for Fostamatinib Disodium Hexahydrate for Adult Patients with Chronic Immune Thrombocytopenia (ITP) in Europe. Media-Rel 2019;.
Media Release -
Bussel J, Arnold D, Boccia R, Boxer M, Cooper N, Hill Q, et al. Long-Term Fostamatinib Treatment of Adults with Immune Thrombocytopenia (Itp) During the Phase 3 Clinical Trial Program. EHA-2019 2019; abstr. PF703.
Available from: URL: https://library.ehaweb.org/eha/2019/24th/266502/j.bussel.long-term.fostamatinib.treatment.of.adults.with.immune.html?f=listing%3D3%2Abrowseby%3D8%2Asortby%3D2%2Amedia%3D3%2Ace_id%3D1550 -
Rigel Pharmaceuticals. Rigel Granted Orphan Drug Designation for Fostamatinib in ITP. Media-Rel 2015;.
Media Release -
Rigel Pharmaceuticals. Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP. Media-Rel 2017;.
Media Release -
Rigel Pharmaceuticals. Rigel Announces First Quarter 2016 Financial Results. Media-Rel 2016;.
Media Release -
Bussel JB, Arnold DM, Boxer MA, Cooper N, Mayer J, Zayed H, et al. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am-J-Hematol 2019;94(5):546-553.
PubMed | CrossRef Fulltext -
Rigel Pharmaceuticals. New TAVALISSE(Rm) Data Analyses To Be Presented at International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress. Media-Rel 2021;.
Media Release -
Rigel Pharmaceuticals. Rigel Announces Post-hoc Data Analysis of TAVALISSE(R)in Adult Patients with Immune Thrombocytopenia Published in the British Journal of Haematology. Media-Rel 2020;.
Media Release
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