A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Sponsors

Lead Sponsor: Rigel Pharmaceuticals

Source Rigel Pharmaceuticals
Brief Summary

The primary objectives of this study are:

- To establish the efficacy of fostamatinib in placebo crossover subjects with warm antibody autoimmune hemolytic anemia (wAIHA)

- To determine the ability to maintain a response in subjects receiving fostamatinib for wAIHA

Overall Status Active, not recruiting
Start Date October 30, 2019
Completion Date December 2022
Primary Completion Date December 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Durable Response 104 weeks
Durable Response and Hemoglobin Response 104 weeks
Secondary Outcome
Measure Time Frame
Hemoglobin Response by Week 24 24 weeks
Partial Hemoglobin Response 24 Weeks
Median Hemoglobin Value at Week 24 24 weeks
Median change from baseline in hemoglobin at week 24 24 Weeks
Durable Response and Maintain a Hemoglobin Response at 24 and 36 Weeks 36 Weeks
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: Fostamatinib disodium

Description: Fostamatinib (100mg PO bid or 150 mg PO bid) The dose may be reduced at any time to a dose as low as fostamatinib 100 mg PO qd or matching placebo if dose limiting adverse events are observed.

Arm Group Label: Fostamatinib

Eligibility

Criteria:

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 completed all 24 weeks of participation in the study C-935788-057.

Exclusion Criteria:

1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.

Gender: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Healthy Volunteers: No

Location
Facility:
University of Southern California | Los Angeles, California, 90033, United States
John Hopkins Bayview Medical Center | Baltimore, Maryland, 21205, United States
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada, 89169, United States
University of Washington | Seattle, Washington, 98109, United States
Cancer Trials Unit | Brisbane, Queensland, 4201, Australia
The Alfred Hospital | Melbourne, Victoria, 3004, Australia
Hanusch-Krankenhaus | Vienna, 1140, Austria
AZ Nikolaas | Sint-Niklaas, 9100, Belgium
Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika | Brno, 625 00, Czechia
Fakultni nemocnice Ostrava Klinika hematoonkologie | Ostrava, 70852, Czechia
CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses | Pessac, 33603, France
LTD Multiprofile Clinic Consilium Medulla | Tbilisi, 0186, Georgia
M. Zodelava Hematology Centre, Tbilisi | Tbilisi, 0186, Georgia
Universitätsklinikum Essen | Essen, 45147, Germany
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia | Milano, 20122, Italy
Location Countries

Australia

Austria

Belgium

Czechia

France

Georgia

Germany

Italy

United States

Verification Date

October 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Fostamatinib

Type: Experimental

Description: Subjects who at any time during the C-935788-057 study achieved a hemoglobin response in the absence of rescue in the previous 4 weeks or a steroid dose greater than baseline will continue at their current dose (100mg or 150 mg) and regimen in the extension study. All other subjects who enter the extension study will initially receive fostamatinib 100 mg PO bid. Starting at Week 4, the initial fostamatinib dose of 100 mg PO bid will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug, based on the investigator's judgment.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov