A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA) (SOAR)

July 19, 2021 updated by: Rigel Pharmaceuticals

A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences- McMaster University Medical Centre
      • London, Ontario, Canada, N6A 5W9
        • Victoria Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T IE2
        • Jewish General Hospital
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology Associates, PC
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Loma Linda, California, United States, 92350
        • Loma Linda University Cancer Center
      • Los Angeles, California, United States, 90033
        • LAC/USC Health Center
      • San Francisco, California, United States, 94158
        • University of California at San Francisco
      • Whittier, California, United States, 90603
        • The Oncology Institute of Hope and Innovation
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Orange City, Florida, United States, 32763
        • Mid-Florida Hematology & Oncology Centers, P.A.
    • Kentucky
      • Mount Sterling, Kentucky, United States, 40353
        • Montgomery Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine
      • Bethesda, Maryland, United States, 20817
        • Rcca Md Llc
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Midland, Michigan, United States, 48640
        • MidMichigan Health Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Robert Wood Johnson University Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Brody School of Medicine at East Carolina University
      • Salisbury, North Carolina, United States, 28144
        • W.G. "Bill" Hefner VA Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
    • South Carolina
      • Sumter, South Carolina, United States, 29150
        • M. Francisco Gonzalez, M.D., P.A.
    • Texas
      • San Antonio, Texas, United States, 78240
        • Texas Oncology San Antonio Medical Center
      • Webster, Texas, United States, 77598
        • Clear Lake Specialties
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subject must have had a diagnosis of primary or secondary warm antibody AIHA.

- Must have failed at least 1 prior treatment regimen for AIHA.

Exclusion Criteria:

  • Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria.
  • Subject with a platelet count of < 30,000/μL.
  • Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.
  • Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fostamatinib 150 mg
Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks
Drug: Fostamatinib 150 mg bid
Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.
Other Names:
  • Tavalisse
  • R935788
  • Fostamatinib
  • R788

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin response
Time Frame: by Week 24
Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin
by Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigel Pharmaceuticals

Investigators

  • Study Director: Rigel Pharmaceuticals, Rigel Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-935788-053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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