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A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Trial Profile

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Status: Completed
Phase of Trial: Phase III

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
  • Most Recent Events

    • 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.

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
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

  • 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

  1. Rigel Pharmaceuticals. Fostamatinib Study Results Continue to Trend Positive. Media-Rel 2017;.

    Media Release
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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

Authors

Author Total Publications First Author Last Author
Abdallah A 1 - -
Arnold D 2 - -
Arnold DM 2 - -
Boccia R 4 2 -
Boxer M 2 - -
Boxer MA 3 - -
Bussel J 2 2 -
Bussel JB 5 2 2
Cadieux B 1 - -
Cooper N 7 1 -
Duliege A-M 3 - 2
Duliege AM 2 - 2
FIT Clinical Trial Investigators 1 - 1
Flynn R 1 - -
Ghanima W 4 - -
Grossbard E 1 - -
Hellmann A 1 - -
Hill Q 2 - -
Hill QA 2 - -
Homenda W 1 - -
Khalafallah AA 1 - -
Kreychman Y 1 - -
Liles D 1 - -
Liles DK 1 - -
Markovtsov V 1 - -
Mayer J 2 - -
McCrae K 1 - -
Numerof R 1 - -
Numerof RP 2 - -
Olender B 1 - -
Rigel Pharmaceuticals 2 2 2
Scholzberg M 1 - -
Shertzer G 1 - -
Sholzberg M 2 - -
Sivcheva L 1 - -
Tarantino MD 2 - -
Tian H 1 - -
Todd L 1 - -
Todd LK 1 - -
Tong S 6 - -
Trelinski J 1 - -
Windyga J 1 - -
Zaja F 1 - -
Zayed H 4 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Alexander Röth, MD Universittsklinikum Essen Germany
Alois Lang, MD
43 (0)5522 303 2301
show details
LKH Feldkirch at LKH Rankweil Austria
Andrei Colita, MD
+40722661228
show details
Spitalul Clinic Coltea, Hematologie Romania
Andrzej Hellmann, MD
4858 349 22 30
show details
Uniwersyteckie Centrum Kliniczne Poland
Aristoteles Giagounidis, MD
211 44002501
show details
Marien Hospital Duesseldorf Germany
Axel Nogai, MD
1 30 00 450 513537
show details
Charit Berlin - Campus Benjamin Franklin Germany
Bjorn Gjertsen, MD
47 55972890
show details
Haukeland University Hospital Norway
Bradley Cohen, MD
845-362-1750
show details
Hematology Oncology Associates of Rockland Division of Highland Medical PC USA
Dariusz Woszczyk, MD
+48 606 625 611
show details
Szpital Wojewodzki w Opolu Poland
David Valcarcel, MD
34 932746100
show details
Hospital Universitari Vall D'Hebron Spain
Elisa Orna Montero, MD
34 93 497 88 68
show details
Hospital Universitari Germans Trias i Pujol Spain
Evgueniy Hadjiev, MD
+ 359 29230588
show details
UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology Bulgaria
Galafteon Oltean, MD
+40722771065
show details
Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie Romania
Ingrid Pabinger-Fasching, MD
+431 40400 2757
show details
Medizinische Universitaet Wien / AKH Wien Austria
Isidro Jarque Ramos, MD
34 961245876
show details
Hospital Universitari i Politécnic La Fe de Valencia Spain
Jaromir Gumulec, MD
420 734648047
show details
Fakultni nemocnice Ostrava Czech-Republic
Jerzy Windyga, MD
48 22 34 96 157
show details
Instytut Hematologii I Transfuzjologii Poland
Jiří Mayer, MD Fakultni nemocnice Brno Czech-Republic
Krzysztof Giannopoulos, MD
+4881 5345468
show details
Specjalistyczny Gabinet Lekarski Poland
Liliya Sivcheva, MD
+359 92625561
show details
MHAT Hristo Botev, AD, Vratsa, First Internal Department Bulgaria
Lowe A
Phone: 1.512-502-5353
alowe@rigel.com
show details
Rigel Pharmaceuticals
-
Marek Trneny, MD
22496 2527
show details
Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie Czech-Republic
Maria Podolak-Dawidziak, MD
+74817 842576
show details
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw Poland
Maria Teresa Alvarez Roman, MD
34 917277225
show details
Hospital Universitariola Paz Spain
Mario von Depka Prondzinski, MD
49 51133059911
show details
Werlhof Institut GmbH Germany
Mathias Rummel, MD
641 985 42650
show details
Universitaetsklinikum Giessen und Marburg (UKGM) Germany
Michael Fillitz, MD
+43 1 91021 85440
show details
Hanusch-Krankenhaus Wiener Gebietskrankenkasse Austria
Nikolay Tzvetkov, MD
359 64 886335
show details
UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology Bulgaria
Olga Cerna, MD
+420 267 16 2887
show details
Fakultni nemocnice Kralovske Vinohrady Czech-Republic
Petr Svoboda, MD, PhD
+359 602 514303
show details
Hospital Kyjov Czech-Republic
Rigel Pharmaceuticals, Inc.
clinicaltrials@rigel.com
show details
Rigel Pharmaceuticals, Inc.
-
Tadeusz Robak, MD
+4842 689 5191
show details
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi Poland
Toshko J Lissitchkov, MD, PhD, DSc
+359 2 9701 235
show details
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
Spitalul Clinic Colentina, Hematologie Romania
Waleed Ghanima, MD
+4769860000
show details
Sykehuset Østfold Fredrikstad Norway
Wojciech Homenda, MD
4859 846 03 50
show details
Wojewodzki Szpital Specjalistyczny im. J. Korczaka Poland
Zbigniew Walter, MD
4812 4247620
show details
Szpital Uniwersytecki Poland

Centres

Centre Name Location Trial Centre Country
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
-
-
Rigel Pharmaceuticals, Inc.
-
-
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

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