NCT00926354

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: BioMAS Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy Induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	AS101	intravenous infusions of 3mg/m2 AS101 twice a week in addition to the standard chemotherapy regimen during the following 4 chemotherapy courses.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-06-23
• Last updated: 2011-06-21

Locations

1 site across 1 country: Israel