Status:
TERMINATED
Application of AS101 for the Treatment of Thrombocytopenia in Solid Tumor Patients
Lead Sponsor:
BioMAS Ltd
Conditions:
Chemotherapy Induced Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 charac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00926354
Start Date
August 1 2009
End Date
August 1 2010
Last Update
June 21 2011
Active Locations (1)
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1
Meir Medical Center
Kfar Saba, Israel