Application of AS101 for the Treatment of Thrombocytopenia in Solid Tumor Patients
This study has been terminated.
(Sponsor's considerations)
Sponsor:
BioMAS Ltd
Information provided by:
BioMAS Ltd
ClinicalTrials.gov Identifier:
NCT00926354
First received: June 17, 2009
Last updated: June 19, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapy Induced Thrombocytopenia |
Drug: AS101 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Open Study to Evaluate Safety and Efficacy of AS101 for the Treatment of Thrombocytopenia in Solid Tumor |
Resource links provided by NLM:
Further study details as provided by BioMAS Ltd:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
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); [ Time Frame: continously during study and 6 months after study termination ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | BioMas LTD |
| ClinicalTrials.gov Identifier: | NCT00926354 History of Changes |
| Other Study ID Numbers: | #71 REV 00 |
| Study First Received: | June 17, 2009 |
| Last Updated: | June 19, 2011 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Thrombocytopenia Blood Platelet Disorders Hematologic Diseases Ammonium trichloro(dioxoethylene-O,O'-)tellurate Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Radiation-Protective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013