Application of AS101 for the Treatment of Thrombocytopenia in Solid Tumor Patients

Study Overview
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Brief Summary
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Chemotherapy Induced Thrombocytopenia is a common side-effect of bone marrow suppression as a result of a chemotherapy treatment. AS101 is a tellurium based small compound with immunomodulating characteristics which attributed to the direct inhibition of the anti-inflammatory cytokine IL-10. AS101 was previously shown to induce a significant reduction in thrombocytopenia that accompany cancer therapy with no major toxicity . This phase II randomized open study will evaluate the efficacy of AS101 for the treatment of chemotherapy induced thrombocytopenia in patients with various solid tumors.

Official Title
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Phase II Open Study to Evaluate Safety and Efficacy of AS101 for the Treatment of Thrombocytopenia in Solid Tumor

Conditions
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Chemotherapy Induced Thrombocytopenia

Intervention / Treatment
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* Drug: AS101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Appropriate histology of solid tumors. Platelet counts < 70,000/μl. Performance Status (PS) of 0-2 Adequate renal function: Serum creatinine ≤1.5 mg/dL Adequate liver function: Serum (total) bilirubin ≤ 1.5 ULN. AST, ALT ≤ 2.5 x ULN in patients without liver metastases, ≤ 5 x ULN in patients with liver metastases. Albumin ≥ 2.5 g/dL (Only for patients who will receive AS101). INR ≤ 1.5 and PTT ≤ 1.5 x ULN (Only for patients who will receive AS101). Exclusion Criteria: Patients unable to provide fully informed consent. Women who are pregnant or breast feeding. The patient is participating in another trial of an investigational drug or has done so within 28 days prior to the pre-treatment visit. The patient has congestive heart failure-New York Heart Association (CHF-NYHA) grade II or higher, and/or myocardial infarction within the last 12 months, or any cardiac disorder which in the opinion of the Investigator would put the patient at risk. The patient has a history of chronic alcohol or drug abuse within the last 5 years. The patient has any other clinically significant medical condition, psychiatric condition or laboratory abnormality which would, in the judgment of the Investigator, interfere with the patient's ability to participate in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AS101 infusion<br>Twenty patients who developed thrombocytopenia after a chemotherapy course will receive i.v. infusions of 3mg/m2 AS101 twice a week in addition to the standard chemotherapy regimen, during the following 4 chemotherapy courses. | Drug: AS101<br>* intravenous infusions of 3mg/m2 AS101 twice a week in addition to the standard chemotherapy regimen during the following 4 chemotherapy courses.<br>|
| No Intervention: Control group<br>Twenty patients who developed thrombocytopenia during chemotherapy course will be treated according to standard of care and will not receive the investigational product. Their medical condition will be followed and a complete blood count will be performed routinely once weekly. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of thrombocytopenia events (platelets <70,000) over the study period of the study groups |  | continously during study and 6 months after study termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Safety and tolerability; Thrombocytopenia events that caused treatment delays and chemotherapy dose; reductions; Progression Free Survival (PFS); Response Rate (RR); |  | continously during study and 6 months after study termination |