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

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.

Study Overview

• Status: Terminated
• Conditions: Chemotherapy Induced Thrombocytopenia
• Intervention / Treatment: Drug: AS101

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AS101 infusion; Twenty patients who developed thrombocytopenia after a chemotherapy course will receive i.v. infusions of 3mg/m2 AS101 twice a week in addition to the standard chemotherapy regimen, during the following 4 chemotherapy courses.	Drug: AS101; intravenous infusions of 3mg/m2 AS101 twice a week in addition to the standard chemotherapy regimen during the following 4 chemotherapy courses.
No Intervention: Control group; Twenty patients who developed thrombocytopenia during chemotherapy course will be treated according to standard of care and will not receive the investigational product. Their medical condition will be followed and a complete blood count will be performed routinely once weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of thrombocytopenia events (platelets <70,000) over the study period of the study groups	continously during study and 6 months after study termination

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: BioMAS Ltd
• Investigators: Principal Investigator: Baruch Klein, Prof, Meir Medical Center, Kfar Saba, Israel

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: June 17, 2009
• First Submitted That Met QC Criteria: June 21, 2009
• First Posted (Estimate): June 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 21, 2011
• Last Update Submitted That Met QC Criteria: June 19, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Radiation-Protective Agents; Ammonium trichloro(dioxoethylene-O,O'-)tellurate
• Other Study ID Numbers: #71 REV 00