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

NCT ID: NCT00926354

Last Updated: 2011-06-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-08-31

Brief Summary

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.

Conditions

Chemotherapy Induced Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AS101 infusion

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.

Group Type: EXPERIMENTAL

AS101

Intervention Type: DRUG

intravenous infusions of 3mg/m2 AS101 twice a week in addition to the standard chemotherapy regimen during the following 4 chemotherapy courses.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AS101

intravenous infusions of 3mg/m2 AS101 twice a week in addition to the standard chemotherapy regimen during the following 4 chemotherapy courses.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioMAS Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

BioMas LTD

Principal Investigators

Baruch Klein, Prof

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center, Kfar Saba, Israel

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Other Identifiers

#71 REV 00

Identifier Type: -

Identifier Source: org_study_id