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

Phase 2
18 Years
Not Enrolling
Chemotherapy Induced Thrombocytopenia

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of thrombocytopenia events (platelets <70,000) over the study period of the study groups

Outcome Time Frame:

continously during study and 6 months after study termination

Safety Issue:


Principal Investigator

Baruch Klein, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Meir Medical Center, Kfar Saba, Israel


Israel: Ministry of Health

Study ID:

#71 REV 00



Start Date:

August 2009

Completion Date:

August 2010

Related Keywords:

  • Chemotherapy Induced Thrombocytopenia
  • Thrombocytopenia