Clinical trial NCT00926354: Application of AS101 for the Treatment of Thrombocytopenia in Solid Tumor Patients
Official title: Phase II Open Study to Evaluate Safety and Efficacy of AS101 for the Treatment of Thrombocytopenia in Solid Tumor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chemotherapy Induced Thrombocytopenia
Lead sponsor: BioMAS Ltd
Sponsor class: INDUSTRY
First posted: 2009-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of thrombocytopenia events (platelets <70,000) over the study period of the study groups
timeFrame: continously during study and 6 months after study termination
Secondary outcomes:
measure: Evaluation of Safety and tolerability; Thrombocytopenia events that caused treatment delays and chemotherapy dose; reductions; Progression Free Survival (PFS); Response Rate (RR);
timeFrame: continously during study and 6 months after study termination
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center, Kfar Saba, Israel
name: Baruch Klein, Prof
role: PRINCIPAL_INVESTIGATOR
References: