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A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Trial Profile

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2023

At a glance

  • Drugs Fostamatinib (Primary)
  • Indications Idiopathic thrombocytopenic purpura
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms FIT; FIT3; HAEM 3426
  • Sponsors Rigel Pharmaceuticals
  • Most Recent Events

    • 02 Nov 2023 According to a Rigel Pharmaceuticals media release, long-term efficacy and safety of fostamatinib in Japanese patients will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, California and virtually.
    • 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.

Trial Overview

Purpose

This phase III, open label extension study is designed to determine whether fostamatinib is safe and effective in treating patients with persistent/chronic immune thrombocytopenic purpura (ITP) over a 5 year period.

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

Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Fostamatinib in 047/048 or 049):Version 1

description: Percentage of subjects who achieved platelet count of at least 50,000/µL within 12 Weeks of beginning treatment up to 12 months was analyzed among all subjects who received active treatment in one of the prior studies (C788-047 or C788-048), in the current extension study (C788-049), or in both prior and current studies. Treated Population was defined as all enrolled and treated subjects.
time_frame: Up to 12 months

Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Placebo in 047/048 and Fostamatinib 049): Version 2

description: A within-subject, between-study comparison of platelet counts for subjects who were previously treated with placebo in one of the prior studies (C788-047 or C788-048) was prospectively defined in the protocol (version 2). Achievement of platelet response by 12 weeks and maintenance of platelet response for 12 weeks was analyzed among subjects who had been randomized to placebo in one of the prior studies (C788-047 or C788-048). Treated Population was defined as all enrolled and treated subjects.
time_frame: Up to 12 months

Other Endpoints

Duration of Platelet Response Based on Platelet Count and Rescue Medication

description: The duration of platelet response was defined as the time from when the subject first achieved a platelet count of at least 50,000/µL, until the first of 2 visits with platelet counts < 50,000/µL that were at least 4 weeks apart without an intervening visit with a platelet count less than equal to (≤) 50,000/µL unrelated to rescue therapy. Duration of platelet response was analyzed using the Kaplan-Meier method. Treated Population was defined as all enrolled and treated subjects. Here, a number of subjects analyzed included all subjects evaluable for this endpoint.
time_frame: Up to 12 months

Percentage of Subjects in Whom a Reduction in the Dose of Concomitant ITP Therapy Can be Achieved While Maintaining an Adequate Platelet Count

description: The percentage of subjects in whom a reduction in the dose of concomitant ITP therapy could be achieved while maintaining an adequate platelet count, the reduction event was clarified to apply only to reductions in the dose of concomitant ITP therapy occurring within a period of platelet response and the reduction event was not be prompted by an adverse event.
time_frame: Up to 12 months [1]

Diseases Treated

Indication Qualifiers Patient Segments
Idiopathic thrombocytopenic purpura treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 150

    Actual: 123

  • Sex male & female
  • Age Group 20-88 years(median age 52 years); adult; elderly

Patient Inclusion Criteria

- Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response. - Able and willing to give written informed consent

Patient Exclusion Criteria

- Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response - Poorly controlled hypertension during Study C935788-047 or Study C935788-048 - Significant infection, an acute infection such as influenza, or known inflammatory process

Trial Details

Identifiers

Identifier Owner
NCT02077192 ClinicalTrials.gov: US National Institutes of Health
EudraCT2013-005454-30 European Clinical Trials Database
16835 United Kingdom Clinical Research Network
C935788-049 -

Organisations

  • Sponsors Rigel Pharmaceuticals
  • Affiliations Kissei Pharmaceutical; Rigel Pharmaceuticals

Trial Dates

  • Initiation Dates

    Planned : 01 Jul 2014

    Actual : 01 Oct 2014

  • Primary Completion Dates

    Planned : 01 Mar 2020

    Actual : 02 Jun 2020

  • End Dates

    Planned : 01 Mar 2020

    Actual : 02 Jun 2020

Other Details

  • Design multicentre; open; prospective
  • Phase of Trial Phase III
  • Location Australia; Austria; Bulgaria; Canada; Czech Republic; Denmark; England; France; Germany; Hungary; Italy; Netherlands; Norway; Poland; Romania; Spain; United Kingdom; USA
  • Focus Adverse reactions; Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
FostamatinibPrimary Drug Oral Tablet

Fostamatinib Disodium

Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
Drug: Fostamatinib Disodium (Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day) Other Name: R935788, R788, Fostamatinib

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] .

Updated results from the open-label extension demonstrated that 56% of subjects with a stable response maintained the response for ≥24 months. Of 27 patients with a stable response, 21 (78%) maintained the response at Month 12 of fostamatinib treatment, and 15 (56%) at Month 24. At Month 12, median platelet count for the 49 subjects was 72,000/µL (range: 9000-333,000 µL). For the 32 subjects at Month 24, median platelet count was 80,500/µL (range: 7000-315,000/µL). An overall platelet response was achieved by 57/123 (46%) patients. In the FIT phase III long-term extension study 049, 118 patients who responded to fostamatinib in the parent studies (047 and 048) and exposed to fostamatinib for a median of 13 months through the combined parent and 049 trials had a median platelet count of 96 000/µL of blood.In addition, 41 out of 44 former placebo patients from the 047 and 048 studies that enrolled in the 049 study, 22% (n = 9/41, p = 0.0078) achieved a prospectively defined stable platelet response [3] [2] [4] [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 [5] .

In the FIT phase III long-term extension study 049, AEs were reported by 95 (77%) patients and were mild/moderate in 92 (75%). The most common AEs were diarrhea and hypertension, which were manageable with targeted treatment, fostamatinib dose modifications, or treatment withdrawal (5 patients withdrew due to diarrhea and none due to hypertension). Serious adverse events (SAE) were reported in 28 patients (23%), were considered unrelated to fostamatinib in 23 patients (19%) and included bleeding-related SAEs in 11 subjects (9%), thrombocytopenia in 6 subjects (5%), epistaxis in 3 (2%), sepsis in 2 (2%) and transaminases increased in 2 (2%). Adverse events were consistent with those reported during the placebo-controlled trials [3]

Publications

  1. Duliege A-M, Arnold DM, Boccia R, Boxer M, Cooper N, Hill QA, et al. Two-Year Safety and Efficacy Outcomes with Fostamatinib in Adult Patients with Immune Thrombocytopenia (ITP): Open-Label Extension to Phase 3 Trial Program. ASH-Hem-2018 2018; abstr. 736.

    Available from: URL: https://ash.confex.com/ash/2018/webprogram/Paper110482.html
  2. Rigel Pharmaceuticals. Fostamatinib Study Results Continue to Trend Positive. Media-Rel 2017;.

    Media Release
  3. 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
  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. 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
  6. 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
  7. 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
  8. 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
Arnold DM 2 - -
Boccia R 4 2 -
Boxer M 1 - -
Boxer MA 3 - -
Bussel JB 5 1 3
Cooper N 5 1 -
Duliege A-M 2 1 -
Duliege AM 1 - 1
FIT Clinical Trial Investigators 1 - 1
Flynn R 1 - -
Ghanima W 3 - -
Hill Q 1 - -
Hill QA 3 - -
Kreychman Y 1 - -
Liles DK 1 - -
Mayer J 1 - -
Numerof RP 2 - -
Olender B 1 - -
Rigel Pharmaceuticals 3 3 3
Shertzer G 1 - -
Sholzberg M 3 - -
Tarantino MD 2 - -
Tian H 1 - -
Todd L 1 - -
Todd LK 1 - -
Tong S 5 - -
Zayed H 2 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Ann M. Lowe, MD
1180 Veterans Boulevard
South San Francisco
Postcode: CA 94080
United States
Telephone: 1 415 309 7672
Fax: 1 650 624 1282
alowe@rigel.com
show details
Rigel Pharmaceuticals USA
Rigel Pharmaceuticals, Inc. Rigel Pharmaceuticals, Inc.
-

Centres

Centre Name Location Trial Centre Country
Arizona Oncology Associates Tucson, Arizona USA
Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" - Clinica Ematologica Udine Italy
Bleeding & Clotting Disorders Institute Peoria, Illinois USA
Cancer and Haematology Centre Oxford United-Kingdom
Center for Cancer and Blood Disorders Bethesda, Maryland USA
Colchester General Hospital Colchester, Essex United-Kingdom
Concord Repatriation General Hospital Concord, New South Wales Australia
East Carolina University, Brody School of Medicine Greenville, North Carolina USA
Fakultni nemocnice Brno Brno Czech-Republic
Fakultni nemocnice Ostrava Ostrava-Poruba Czech-Republic
HAGA ziekenhuis Den Haag, NL Netherlands
Hamilton Health Sciences Corporation Hamilton, Ontario Canada
Hanusch-Krankenhaus Wiener Gebietskrankenkasse Vienna Austria
Haukeland universitetssykehus, Helse Bergen HF Bergen Norway
Herlev Hospital Herlev, DK Denmark
Horizon Oncology Research, Inc Lafayette, Indiana USA
Hospital Universitari i Politécnic La Fe de Valencia Valencia Spain
Hospital Universitari Vall d'Hebron Barcelona Spain
Hospital Universitario La Paz Madrid Spain
Imperial College Healthcare NHS Trust London United-Kingdom
Instytut Hematologii I Transfuzjologii Warszawa Poland
Istituto di Ematologia "Lorenzo e Ariosto Seràgnoli" Bologna, BO Italy
James Paget University Hospital Norfolk United-Kingdom
Kent & Canterbury Hospital Kent United-Kingdom
Launceston General Hospital Launceston, Tasmania Australia
Leicester Royal Infirmary Leicester United-Kingdom
Liverpool Hospital Liverpool, New South Wales Australia
Lkinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne Gdansk Poland
MHAT Hristo Botev, AD, Vratsa, First Internal Department Vratsa Bulgaria
Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz. Belgyogyaszati Klinika Pecs Hungary
Perth Blood Institute Nedlands, Western Australia Australia
Prince of Wales Hospital Randwick, New South Wales Australia
Rigel Pharmaceuticals South San Francisco USA
Rigel Pharmaceuticals, Inc.
-
-
Royal Liverpool University Hospital Liverpool United-Kingdom
Royal Victoria Infirmary Newcastle-upon-Tyne, UK United-Kingdom
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw Wroclaw, Dolnoslaski Poland
Signal Point Clinical Research Center LLC Middletown, Ohio USA
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
SPZOZ Szpital Uniwersytecki w Krakowie Pracownia Separacji Krwinek i Bank Komórek Krwiotwórczych Klinika Hematologii Kraków Poland
St. James's Hospital West Yorkshire United-Kingdom
St. Michael's Hospital Toronto, Ontario Canada
Sykehuset Østfold Kalnes Grålum Norway
Szpital Wojewodzki w Opolu Opole Poland
The Alfred Melbourne, Victoria Australia
UMHAT Aleksandrovska, EAD Sofia Bulgaria
UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology Pleven Bulgaria
University College Hospital London United-Kingdom
University Hospital of North Midlands NHS Trust, Royal Stoke University Hospital Stoke-on-Trent United-Kingdom
W.G. "Bill" Hefner VA Medical Center Salisbury, North Carolina USA
Weill Cornell Medical College/New York Presbyterian Hospital New York, New York USA
Weill Cornell Medicine New York, New York USA
Westmead Hospital Westmead, New South Wales Australia
Wojewodzki Szpital Specjalistyczny im. J. Korczaka Slupsk, PO Poland
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi Lodz Poland

Trial History

Event Date Event Type Comment
15 Dec 2023 Other trial event Last checked against ClinicalTrials.gov record. Updated 15 Dec 2023
02 Nov 2023 Other trial event According to a Rigel Pharmaceuticals media release, long-term efficacy and safety of fostamatinib in Japanese patients will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, California and virtually. Updated 03 Nov 2023
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
21 May 2021 Status change - completed Status changed from active, no longer recruiting to completed. Updated 28 May 2021
01 Mar 2021 Other trial event This trial has been completed in Netherlands (Global end Date: 03 Feb 2021). Updated 01 Mar 2021
01 Mar 2021 Other trial event Last checked against European Clinical Trials Database record. Updated 01 Mar 2021
23 Feb 2021 Other trial event The trial has been completed in Hungary, according to European Clinical Trials Database record. Updated 23 Feb 2021
25 Nov 2020 Other trial event The trial has been completed in Italy, according to European Clinical Trials Database record. Updated 26 Nov 2020
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
08 Jul 2020 Other trial event This trial was completed in poland, according to European Clinical Trials Database. Updated 08 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
26 May 2020 Other trial event This trial was completed in Bulgaria, according to European Clinical Trials Database. Updated 26 May 2020
19 Mar 2020 Other trial event This trial has been completed in Czech Republic, according to European Clinical Trials Database record. Updated 19 Mar 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 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
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
13 Jun 2019 Other trial event According to a Rigel Pharmaceuticals media release, data from the study will be presented at the 24 Congress of the European Hematology Association (EHA) 2019. Updated 01 Jul 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
04 Dec 2018 Results Results of post-hoc analysis (n=123; data cutoff 8 March 2018) evaluating safety and efficacy of Fostamatinib in adult patients with Immune Thrombocytopenia presented at the 60th Annual Meeting and Exposition of the American Society of Hematology Updated 28 Jan 2019
01 Nov 2018 Other trial event According to a Rigel Pharmaceuticals media release, data from this trial will be presented at the 60th American Society of Hematology (ASH) Annual Meeting & Exposition to be held December 1-4, 2018, in San Diego, CA. Updated 13 Nov 2018
04 Jul 2018 Completion date Planned End Date changed from 1 Apr 2018 to 1 Mar 2020. Updated 04 Jul 2018
04 Jul 2018 Other trial event Planned primary completion date changed from 1 Apr 2018 to 1 Mar 2020. Updated 04 Jul 2018
20 Jun 2018 Other trial event According to a Rigel Pharmaceuticals media release, data will be presented at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting. Updated 25 Jun 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
01 Mar 2018 Other trial event According to a Rigel Pharmaceuticals media release, data from this study will be presented at the 4th Biennial Summit of the Thrombosis & Hemostasis Societies of North America 2018. Updated 07 Mar 2018
21 Aug 2017 Completion date Planned End Date changed from 1 Oct 2017 to 1 Apr 2018. Updated 28 Aug 2017
21 Aug 2017 Other trial event Planned primary completion date changed from 1 Oct 2017 to 1 Apr 2018. Updated 28 Aug 2017
11 Aug 2017 Other trial event This trial was completed in Austria, according to European Clinical Trials record. Updated 11 Aug 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
16 Mar 2017 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 22 Mar 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 Interim results Interim results (data cut off September 2016) published in the Rigel Pharmaceutical's Media Release Updated 03 Feb 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
02 Oct 2016 Other trial event The study has been completed in Spain. Updated 05 Oct 2016
29 Sep 2016 Other trial event This trial was completed in Denmark, according to European Clinical Trials Database. Updated 29 Sep 2016
29 May 2015 Other trial event New source identified and integrated (United Kingdom Clinical Research Network; 16835) Updated 29 May 2015
11 Oct 2014 Status change - recruiting Status changed from not yet recruiting to recruiting as reported by European Clinical Trials Database. Updated 21 Oct 2014
19 Aug 2014 Other trial event New source integrated (European Clinical Trials Database: EudraCT2013-005454-30). Updated 19 Aug 2014
13 Mar 2014 New trial record New trial record Updated 13 Mar 2014

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.

    Available from: URL: http://clinicaltrials.gov
  2. Rigel Pharmaceuticals. Rigel Announces Fourth Quarter 2016 and Year End 2016 Financial Results and Provides Company Update. Media-Rel 2017;.

    Media Release
  3. Duliege A-M, Arnold DM, Boccia R, Boxer M, Cooper N, Hill QA, et al. Two-Year Safety and Efficacy Outcomes with Fostamatinib in Adult Patients with Immune Thrombocytopenia (ITP): Open-Label Extension to Phase 3 Trial Program. ASH-Hem-2018 2018; abstr. 736.

    Available from: URL: https://ash.confex.com/ash/2018/webprogram/Paper110482.html
  4. Rigel Pharmaceuticals. Fostamatinib Study Results Continue to Trend Positive. Media-Rel 2017;.

    Media Release
  5. 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
  6. 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
  7. 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
  8. Rigel Pharmaceuticals. Rigel Announces Poster Presentations at FOCIS Annual Meeting. Media-Rel 2018;.

    Media Release
  9. United Kingdom Clinical Research Network. Trial-Reg 2016;.

    Available from: URL: http://www.ukcrn.org.uk
  10. European Clinical Trials Database. Trial-Reg 2023;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  11. Rigel Pharmaceuticals. Rigel Announces Two Fostamatinib Presentations at the 4th Biennial Summit of the Thrombosis & Hemostasis Societies of North America. Media-Rel 2018;.

    Media Release
  12. 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
  13. 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
  14. 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
  15. 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
  16. Rigel Pharmaceuticals. Rigel to Present Two Posters Highlighting Fostamatinib at the 24 Congress of the European Hematology Association (EHA). Media-Rel 2019;.

    Media Release
  17. 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
  18. 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
  19. Rigel Pharmaceuticals. Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP. Media-Rel 2017;.

    Media Release
  20. 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
  21. 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
  22. Rigel Pharmaceuticals. Rigel Announces Poster Presentations at the 65th American Society of Hematology Annual Meeting and Exposition. Media-Rel 2023;.

    Media Release
  23. Rigel Pharmaceuticals. Rigel to Present Data on Fostamatinib in Three Presentations at the 60th American Society of Hematology Annual Meeting & Exposition. Media-Rel 2018;.

    Media Release
  24. 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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