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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

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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

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At a glance

  • Drugs Fostamatinib (Primary)
  • Indications Idiopathic thrombocytopenic purpura
  • Focus Registrational; Therapeutic Use
  • Acronyms FIT1
  • 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

Outcome

Primary endpoint met - positive

Purpose

This phase III study is designed to investigate the efficacy of fostamatinib [fostamatinib disodium, R935788; Rigel Pharmaceuticals] in patients with persistent/chronic immune thrombocytopenic purpura who have platelet counts below 30,000 platelets/µL.

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

Met on 30 Aug 2016

Stable platelet response of at least 50,000/µL

safety_issue: Yes
time_frame: Baseline to Week 24
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. [1]

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: 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: Week 24

Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 12.

description: Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 12. time_frame: Baseline to Week 12

Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 24.

description: Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 24. time_frame: Baseline to Week 24

Mean of 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: Assessed over the 24-week study period

Mean of 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: Assessed over the 24-week study period [2]

Diseases Treated

Indication Qualifiers Patient Segments
Idiopathic thrombocytopenic purpura treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 75

    Actual: 76

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient Inclusion Criteria

-Males and females, aged ≥ 18 years
-Clinical diagnosis of persistent/chronic ITP for at least 3 months.
-Average platelet count < 30,000/µL (and none > 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts

Patient Exclusion Criteria

- Clinical diagnosis of autoimmune hemolytic anemia - Uncontrolled or poorly controlled hypertension - History of coagulopathy including prothrombotic conditions

Trial Details

Identifiers

Identifier Owner
NCT02076399 ClinicalTrials.gov: US National Institutes of Health
EudraCT2013-005452-15 European Clinical Trials Database
NC-HEM14-2 University of Southern California Norris Comprehensive Cancer Center
C935788-047 -

Organisations

  • Sponsors Rigel Pharmaceuticals
  • Affiliations Kissei Pharmaceutical; Rigel Pharmaceuticals

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2014

    Actual : 14 Jul 2014

  • Primary Completion Dates

    Planned : 01 Jun 2016

    Actual : 21 Apr 2016

  • End Dates

    Planned : 01 Jun 2016

    Actual : 21 Apr 2016

Substudies/Extensions

Patients have the option to enrol in an extension study (see profile 700241986).

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Australia; Canada; Denmark; England; Hungary; Italy; Netherlands; United Kingdom; USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
FostamatinibPrimary Drug Oral Tablet

Fostamatinib Disodium

Subjects begin with Fostamatinib Disodium tablet 100 mg PO bid and increase to 150 mg big after week 4 based on platelet count and tolerability. Drug: Fostamatinib disodium (Fostamatinib (100 mg PO bid or 150 mg PO bid)) 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) over the course of 24 weeks)

Results

Therapeutic efficacy

Phase III: Fostamatinib achieved a stable platelet response in the 18% of patients (n=76) with chronic immune thrombocytopenia (ITP) when compared with placebo (p=0.0261). The patients observed an increased platelet count at week 24, a median of more than 100,000/µL from a baseline median of 16,000/uL. The double-blind, phase III, first FIT 1 trial, which randomised patients in a 2:1 ratio to receive either fostamatinib or placebo [1] . In the phase III FIT 2 study, the fostamatinib response rate was 18%, consistent with the phase III FIT 1 study. A stable platelet response was achieved in only one patient in the placebo group (4%) and therefore the difference between those on treatment and those on placebo did not reach statistical significance (p = 0.152). The combined dataset reveals this difference to be statistically significant (p = 0.007), including the increase in platelet count from a median of 18 500/µL of blood at baseline to more than 100 000/µL at week 24 of treatment in patients who met the primary endpoints. The consistent efficacy of fostamatinib across various clinical and treatment backgrounds was demonstrated by a statistically superior stable platelet response in the fostamatinib group versus the placebo group in all subgroup analyses: prior splenectomy or not; prior exposure to TPO agents or not; platelet counts below or above 15,000/µL of blood at baseline [3] .

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 [4] .

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) [5] .

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 [3] [1] .

Publications

  1. Rigel Pharmaceuticals. Rigel's Fostamatinib Meets Primary Endpoint in Phase 3 Study in Chronic ITP. Media-Rel 2016;.

    Media Release

  2. 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

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

    Media Release

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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 4 4 4
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

Download Data (CSV)
Investigator Centre Name Trial Centre Country
A Khalafallah, MD
31 03 63487111
show details 		Launceston General Hospital Australia
Adrian Newland, MD
44 0203 2460338
show details 		Royal London Hospital United-Kingdom
Agnes Nagy, MD
36 30 3595067
show details 		Pecs University Hungary
Alan Tinmouth, MD
613 737-8899
show details 		Ottawa Hospital Research Institute Canada
Ann Lowe
512-502-5353
alowe@rigel.com
show details 		Rigel Pharmaceuticals USA
Beng H Chong, MD
612 9113 3426
show details 		St George Hospital Australia
Darla Liles, MD
252-744-2560
show details 		Pitt County Memorial Hospital USA
Deepak Chandra, MD
44 0178 2674845
show details 		University Hospital of North Staffordshire United-Kingdom
Donald Arnold, MD
1-905-521-2100
show details 		McMaster University Canada
Elizabeth Agnew, MD
704-638-9000
show details 		Bill Hefner VA Medical Center USA
Fabio Ciceri, MD
39 02 2643 2349
show details 		Ospedale San Raffaele S.r.l. Dipartimento di Oncoematologia Italy
Fabrizio Pane, MD
39 817462068
show details 		Universitã Federico II di Napoli Italy
Farooq Wandroo, MD
44 0121 5073427
show details 		Sandwell General Hospital United-Kingdom
Francesco Zaja, MD
39 0432 559604
show details 		OspedaleCivile-ClinicaEmatologica/PUGD Italy
George Rodgers, MD, PhD
801-585-0236
show details 		University of Utah Health Sciences Center USA
Gillian Evans, MD
44 1227 78315
show details 		Kent & Canterbury Hospital
-
Henrik Frederiksen, MD, PhD
45 21849307
show details 		Dept. of Haematology, Odense University Hospital Denmark
Herdis Larsen, MD
45 99326331
show details 		Aarhus University Hospital Denmark
Hillary S Maitland, MD, MS
434-924-2742
show details 		University of Virginia USA
Howard Liebman, MD
323-865-3950
show details 		University of Southern California USA
Huy Tran, MD
613 978 6644
show details 		Frankston Hospital Australia
Huyen Tran, MD
61 3 9076 2179
show details 		Dept of Haematology, The Alfred Hospital and Monash Medical Centre Australia
Ilona Cunningham, MD
2 9767-5757
show details 		Concord Repatriation General Hospital Australia
James Bussel, MD
212-746-3474
show details 		Weill Cornell Medical College/New York Presbyterian Hospital USA
Jecko Thachil, MD
44 0161 2761234
show details 		Manchester Royal Infirmary United-Kingdom
Jennifer Curnow, MD
61 2 98456274
show details 		Westmead Hospital Australia
Judit Demeter, MD
36 208258644
show details 		Semmelweis University 1st Hungary
Kate Talks, MD
44 0191 12824159
show details 		Royal Victoria Infirmary United-Kingdom
Keith McCrae, MD
216-445-7809
show details 		Cleveland Clinic USA
Lindsay Dunlop, MD
2 87385167
show details 		Liverpool Hospital Australia
Madhavi Venigalla, MD
863-904-1900
show details 		Lakeland Regional Cancer Center USA
Mamta Garg, MD
44 0116 2586293
show details 		Leicester Royal Infirmary United-Kingdom
Manzoor Mangi, MD
44 0143 9453135
show details 		James Paget University Hospital United-Kingdom
Marco Ruggeri, MD
39 444753365
show details 		ULSS 6 Vicenza-Ospedale San Bortolo di Vicenza Italy
Marie Scully, MD
44 0203 4979884
show details 		University College Hospital United-Kingdom
Marion Wood, MD
44 120674 ext 2357/4406
show details 		Colchester General Hospital United-Kingdom
Martin Schipperus, MD
31702102556
show details 		HAGA ziekenhuis Netherlands
Michael Boxer, MD
520-866-0206
show details 		Arizona Oncology Associates USA
Michael Murphy, MD
44 1865 387902
show details 		Oxford University Hospital United-Kingdom
Michael Tarantino, MD
309-692-5337
show details 		Bleeding & Clotting Disorders Institute
-
Michelle Cavo, MD
39 0516363680
show details 		Ematologia - Padigilione 8, Policinico S. Orsola Malpighi, Azienda Ospedaliero Universitaria di Bologna Italy
Michelle Sholzberg, MD
416 864-5389
show details 		St. Michael's Hospital Canada
Mikkel Dorff, MD
4547324808
show details 		Hematological department, Roskilde Hospital Denmark
Nandagopal Vrindavanam, MD
513-423-0504
show details 		Signal Point Clinical Research Center LLC USA
Nichola Cooper, MD
44 0208 3835182
show details 		Hammersmith Hospital, Catherine Lewis Centre United-Kingdom
Quentin Hill, MD
44 0113 2068465
show details 		St. James's Hospital United-Kingdom
Ralph Boccia, MD
240-482-0526
show details 		Center for Cancer and Blood Disorders USA
Rigel Pharmaceuticals, Inc.
clinicaltrials@rigel.com
show details 		Rigel Pharmaceuticals, Inc.
-
Ross Baker, MD
618 92004905
show details 		Perth Blood Institute Australia
Timothy Brighton, MD
61 2 9382-9013
show details 		Prince of Wales Hospital Australia
Tina Dutt, MD, PhD
44 0151 6001292
show details 		Royal Liverpool University Hospital United-Kingdom
Ulrik Overgaard, MD
45 38682206
show details 		Herlev Hospital University of Copenhagen, Department of Hematology L124 Denmark
Wael Harb, MD
765-446-5165
show details 		Horizon Oncology Research, Inc USA
Zoltan Boda, MD
3652 255057
show details 		University of Debrecen Hungary

+ Lead investigator

Show all rows

Centres

Download Data (CSV)
Centre Name Location Trial Centre Country
Aarhus University Hospital Aalborg Denmark
Arizona Oncology Associates Tucson, Arizona USA
Bill Hefner VA Medical Center Salisbury, North Carolina USA
Bleeding & Clotting Disorders Institute Peoria, Illinois USA
Center for Cancer and Blood Disorders Bethesda, Maryland USA
Cleveland Clinic Cleveland, Ohio USA
Colchester General Hospital Colchester, Essex United-Kingdom
Concord Repatriation General Hospital Concord, New South Wales Australia
Dept of Haematology, The Alfred Hospital and Monash Medical Centre Melbourne, Victoria Australia
Dept. of Haematology, Odense University Hospital Odense C, DK Denmark
Ematologia - Padigilione 8, Policinico S. Orsola Malpighi, Azienda Ospedaliero Universitaria di Bologna Bologna Italy
Frankston Hospital Frankston, Victoria Australia
HAGA ziekenhuis Den Haag, NL Netherlands
Hammersmith Hospital, Catherine Lewis Centre London United-Kingdom
Hematological department, Roskilde Hospital Roskilde, DK Denmark
Herlev Hospital University of Copenhagen, Department of Hematology L124 Herlev, DK Denmark
Horizon Oncology Research, Inc Lafayette, Indiana USA
James Paget University Hospital Norfolk United-Kingdom
Kent & Canterbury Hospital Kent, Canterbury United-Kingdom
Lakeland Regional Cancer Center Lakeland, Florida USA
Launceston General Hospital Launceston, Tasmania Australia
Leicester Royal Infirmary Leicester United-Kingdom
Liverpool Hospital Liverpool, New South Wales Australia
Manchester Royal Infirmary Manchester United-Kingdom
McMaster University Hamilton, Ontario Canada
Ospedale San Raffaele S.r.l. Dipartimento di Oncoematologia Milano Italy
OspedaleCivile-ClinicaEmatologica/PUGD Udine Italy
Ottawa Hospital Research Institute Ottawa, Ontario Canada
Oxford University Hospital Oxford United-Kingdom
Pecs University Pecs Hungary
Perth Blood Institute Nedlands, Western Australia Australia
Pitt County Memorial Hospital Greenville, North Carolina USA
Prince of Wales Hospital Randwick, New South Wales Australia
Rigel Pharmaceuticals
clinicaltrials@rigel.com
show details
-
-
Rigel Pharmaceuticals
clinicaltrials@rigel.com
show details 		San Francisco, California USA
Rigel Pharmaceuticals, Inc.
-
-
Rigel Pharmaceuticals, Inc.
-
-
Royal Liverpool University Hospital Liverpool, UK United-Kingdom
Royal London Hospital London United-Kingdom
Royal Victoria Infirmary Newcastle-upon-Tyne United-Kingdom
Saint Francis Medical Group Inc Hartford, Connecticut USA
Sandwell General Hospital West Bromwich United-Kingdom
Semmelweis University 1st Budapest Hungary
Signal Point Clinical Research Center LLC Middletown, Ohio USA
St George Hospital Kogarah, New South Wales Australia
St. James's Hospital West Yorkshire United-Kingdom
St. Michael's Hospital Toronto, Ontario Canada
ULSS 6 Vicenza-Ospedale San Bortolo di Vicenza Vicenza Italy
University College Hospital London United-Kingdom
University Hospital of North Staffordshire Stoke-on-Trent United-Kingdom
University of Debrecen Debrecen Hungary
University of Southern California Los Angeles, California USA
University of Utah Health Sciences Center Salt Lake City, Utah USA
University of Virginia Charlottesville, Virginia USA
Universitã Federico II di Napoli Napoli Italy
Weill Cornell Medical College/New York Presbyterian Hospital New York, New York USA
Westmead Hospital Westmead, New South Wales Australia

+ Lead Centre

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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 Results 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
13 Feb 2019 Other trial event Last checked against the ClinicalTrials.gov record. Updated 13 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 Feb 2018 Other trial event Last checked against European Clinical Trials Database record. Updated 22 Feb 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
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
30 Aug 2016 Other trial event According to a Rigel Pharmaceuticals media release, Further results from the FIT Phase 3 study and long-term extension will be presented at future medical meetings. Updated 19 Sep 2016
30 Aug 2016 Other trial event According to a Rigel Pharmaceuticals media release, if the results of this study are reproduced in the second Phase 3 study (trial profile 700241839) and are supported by the results of a planned interim analysis of the Phase 3 extension study, 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 Results Results published in a Rigel Pharmaceuticals media release. Updated 19 Sep 2016
30 Aug 2016 Endpoint met Primary endpoint has been met. (Stable platelet response of at least 50,000/L), as reported in a Rigel Pharmaceuticals media release. Updated 19 Sep 2016
29 Jul 2016 Status change - completed Status changed from active, no longer recruiting to completed. Updated 04 Aug 2016
24 Jun 2016 Other trial event This trial was completed in Denmark (end date: 2016-04-15). Updated 27 Jun 2016
03 Jun 2016 Other trial event This trial was completed in Hungary (end date: 2016-04-15). Updated 07 Jun 2016
02 Jun 2016 Other trial event This trial was completed in Netherlands. Updated 07 Jun 2016
03 May 2016 Other trial event According to Rigel Pharmaceuticals media release, the results from this study are expected in the middle of 2016. Updated 05 May 2016
19 Apr 2016 Completion date Planned End Date changed from 1 Mar 2016 to 1 Jun 2016. Updated 25 Apr 2016
19 Apr 2016 Other trial event Planned primary completion date changed from 1 Mar 2016 to 1 Jun 2016. Updated 25 Apr 2016
01 Apr 2016 Other trial event According to Rigel media release, results are expected in the middle of 2016. Updated 05 Apr 2016
16 Jan 2016 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting as per ClinicalTrials.gov record. Updated 28 Jan 2016
16 Nov 2015 Completion date Planned End Date changed from 1 Oct 2015 to 1 Mar 2015 as reported by ClinicalTrials.gov. Updated 20 Nov 2015
16 Nov 2015 Other trial event Planned primary completion date changed from 1 Oct 2015 to 1 Mar 2015 as reported by ClinicalTrials.gov. Updated 20 Nov 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
08 Jan 2015 Other trial event Top-line results expected in the first quarter of 2016, according to a Rigel Pharmaceuticals media release. Updated 21 Jan 2015
01 Jan 2015 Other trial event Last checked against the University of Southern California Norris Comprehensive Cancer Center record (NC-HEM14-2) Updated 01 Jan 2015
16 Dec 2014 Protocol amendment Number of treatment arms is increased from 2 to 3, to include fostamatinib 100 mg group. Updated 25 Dec 2014
16 Dec 2014 Other trial event New source identified & integrated (University of Southern California Norris Comprehensive Cancer Center; NC-HEM14-2) Updated 16 Dec 2014
04 Nov 2014 Other trial event According to a Rigel Pharmaceuticals media release, top-line data from this study is expected by the end of 2015. Updated 03 Jul 2015
13 Oct 2014 Other trial event New source identified and integrated (EU Clinical Trials Register; EudraCT2013-005452-15). Updated 13 Oct 2014
23 May 2014 Status change - recruiting Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov record. Updated 08 Jul 2014
12 Mar 2014 Other trial event New source identified and integrated (ClinicalTrials.gov; NCT02076399) Updated 12 Mar 2014
28 Feb 2014 Status change - not yet recruiting Status changed from planning to not yet recruiting as reported by the ClinicalTrials.gov record. Updated 12 Mar 2014
18 Dec 2013 New trial record New trial record Updated 18 Dec 2013
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 18 Dec 2013

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