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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR FOSTAMATINIB DISODIUM

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Clinical Trials for Fostamatinib Disodium

Trial ID Title Status Sponsor Phase Summary
NCT00706342 Pilot Study of Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP) Completed Rigel Pharmaceuticals Phase 2 The purpose of this study is to determine whether Fostamatinib Disodium is safe and effective in the treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP).
NCT00798096 Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma Completed Rigel Pharmaceuticals Phase 2 Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19 patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients exhibit a response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor measurements using CT and PET (when indicated) scans and physical exam at baseline, and scans and physical exam of all disease-involved areas every 8 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30 days following last study drug treatment. Blood samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol defined intervals.
NCT00923481 A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and Renal Cell Carcinomas, and Pheochromocytoma and Thyroid Tumors (Multi-H Completed National Cancer Institute (NCI) Phase 2 Background: - The drug R935788 (fostamatanib disodium) is a kinase inhibitor (i.e., it interferes with cell communication and growth and may prevent tumor growth). - R935788 has shown promising activity in NCI-60 (a panel of 60 diverse human cancer cell lines) against colon cancer, non-small cell lung cancer, and renal cell carcinoma cell lines, as well as in two renal cell xenograft models. - This is an open-label, Phase II study of R935788. Phase I studies in patients with immune thrombocytopenic purpura, rheumatoid arthritis, and lymphoma have demonstrated safety with a continuous dosing schedule, and a maximum tolerated dose has been established. Objectives: - To test an experimental drug called R935788 (fostamatinib disodium) for its ability to stop cancer growth signals, thus slowing the growth of cancer cells in laboratory testing. - To determine the clinical response of R935788 administered orally twice a day on a continuous schedule in patients with colorectal carcinoma, pheochromocytoma, follicular or papillary thyroid cancer, non-small cell lung cancer, hepatocellular, carcinoma of the head and neck, and renal cell carcinoma. - To evaluate the effects, safety, and biochemical response of R935788 therapy. Eligibility: - Patients with colorectal carcinoma, pheochromocytoma, follicular or papillary thyroid cancer, non-small cell lung cancer (excluding squamous cell histology), hepatocellular cancer, carcinoma of the head and neck, and renal cell carcinoma whose disease has progressed after any therapy or who have no acceptable standard treatment options. - Patients must have recovered from toxicities of prior therapies to at least eligibility levels. - Patients who have received radiation or chemotherapy within 4 weeks of study enrollment are not eligible. - Women who are pregnant or breastfeeding are not eligible. Design: - Researchers will conduct the following tests and procedures during the study: - Clinic visits with a physical exam, including vital signs and blood pressure, every other week during cycle 1, and once a month starting with cycle 2. - Blood will be drawn weekly during cycle 1, every other week during cycle 2, and once a month starting with cycle 3; urine tests will be conducted depending on results of blood tests. - Imaging tests, such as computed tomography (CT) scans (a series of x-rays) or ultrasound (an examination using sound waves), will be done every 8 weeks while the patient is receiving R935788. - R935788 will be administered orally twice a day for 28 days (one cycle). Imaging studies will be obtained every two cycles. Patients will fill in a diary to show when they took the medication and to note any side effects. The 28-day treatment cycle will be repeated as long as the patient is tolerating R935788 and the cancer is either stable or getting better. - Researchers will conduct the following additional tests to see how the study is affecting the patient: - Other research blood samples will be collected before treatment, at cycle 1 week 3, at the beginning of cycle 2, and at 8 weeks. - Optional tumor biopsies will be requested before starting treatment, at cycle 1 day 28. - Patients with specific lesions or tumors may be asked for an optional tumor biopsy on day 8.
NCT01167868 A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects Completed AstraZeneca Phase 1 This is a single and multiple ascending dose study in healthy male and female (of non-child bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and blood and urine drug levels of FosD. FosD is being developed for the treatment of rheumatoid arthritis.
NCT01197521 Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. Completed AstraZeneca Phase 3 The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.
NCT01197534 Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. Completed AstraZeneca Phase 3 The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1 year.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Fostamatinib Disodium

Condition Name

Condition Name for Fostamatinib Disodium
Intervention Trials
Rheumatoid Arthritis 6
Immune Thrombocytopenic Purpura 3
Healthy Volunteers 2
Drug Drug Interactions 1
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Condition MeSH

Condition MeSH for Fostamatinib Disodium
Intervention Trials
Arthritis, Rheumatoid 6
Arthritis 6
Purpura, Thrombocytopenic, Idiopathic 4
Purpura, Thrombocytopenic 4
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Clinical Trial Locations for Fostamatinib Disodium

Trials by Country

Trials by Country for Fostamatinib Disodium
Location Trials
United States 183
United Kingdom 28
Canada 20
India 19
Mexico 15
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Trials by US State

Trials by US State for Fostamatinib Disodium
Location Trials
New York 12
Ohio 9
Arizona 9
California 9
North Carolina 8
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Clinical Trial Progress for Fostamatinib Disodium

Clinical Trial Phase

Clinical Trial Phase for Fostamatinib Disodium
Clinical Trial Phase Trials
Phase 3 7
Phase 2 6
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Fostamatinib Disodium
Clinical Trial Phase Trials
Completed 11
Terminated 3
Recruiting 2
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Clinical Trial Sponsors for Fostamatinib Disodium

Sponsor Name

Sponsor Name for Fostamatinib Disodium
Sponsor Trials
AstraZeneca 9
Rigel Pharmaceuticals 6
National Cancer Institute (NCI) 1
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Sponsor Type

Sponsor Type for Fostamatinib Disodium
Sponsor Trials
Industry 15
NIH 1
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Daiichi Sankyo
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US Department of Justice
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