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

Primary Purpose

Chemotherapy Induced Thrombocytopenia

Status

Terminated

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

AS101

About this trial

This is an interventional treatment trial for Chemotherapy Induced Thrombocytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AS101 infusion

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of thrombocytopenia events (platelets <70,000) over the study period of the study groups

Secondary Outcome Measures

Evaluation of Safety and tolerability; Thrombocytopenia events that caused treatment delays and chemotherapy dose; reductions; Progression Free Survival (PFS); Response Rate (RR);

Full Information

NCT ID

NCT00926354

First Posted

June 17, 2009

Last Updated

June 19, 2011

Sponsor

BioMAS Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00926354

Brief Title

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

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Terminated

Why Stopped

Sponsor's considerations

Study Start Date

August 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

BioMAS Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy Induced Thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AS101 infusion

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

AS101

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of thrombocytopenia events (platelets <70,000) over the study period of the study groups

Time Frame

continously during study and 6 months after study termination

Secondary Outcome Measure Information:

Title

Evaluation of Safety and tolerability; Thrombocytopenia events that caused treatment delays and chemotherapy dose; reductions; Progression Free Survival (PFS); Response Rate (RR);

Time Frame

continously during study and 6 months after study termination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baruch Klein, Prof

Organizational Affiliation

Meir Medical Center, Kfar Saba, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Meir Medical Center

City

Kfar Saba

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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