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

NCT00926354 | Terminated Phase 2

• 1 other identifier: #71 REV 00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy Induced Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

AS101 infusion

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

AS101 DRUG

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

AS101 infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioMAS Ltd: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Interventions

ammonium trichloro(dioxoethylene-O,O'-)tellurate

Study Officials

• Baruch Klein, Prof

  Meir Medical Center, Kfar Saba, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 23, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 21, 2011

Record last verified: 2011-06

Locations

IL (1)