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