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

Chemotherapy Induced Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00926354
• Other study ID #: #71 REV 00
• Status: Terminated
• Phase: Phase 2
• First received: June 17, 2009
• Last updated: June 19, 2011
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2011
• Source: BioMAS Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Chemotherapy Induced Thrombocytopenia
• Thrombocytopenia
• Thrombocytosis

Intervention

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

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
BioMAS Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of thrombocytopenia events (platelets <70,000) over the study period of the study groups		continously during study and 6 months after study termination	No
Secondary	Evaluation of Safety and tolerability; Thrombocytopenia events that caused treatment delays and chemotherapy dose; reductions; Progression Free Survival (PFS); Response Rate (RR);		continously during study and 6 months after study termination	Yes

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