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

This study has been terminated.
(Sponsor's considerations)
Sponsor:
Information provided by:
BioMAS Ltd
ClinicalTrials.gov Identifier:
NCT00926354
First received: June 17, 2009
Last updated: June 19, 2011
Last verified: June 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926354

Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
BioMAS Ltd
Investigators
Principal Investigator: Baruch Klein, Prof Meir Medical Center, Kfar Saba, Israel
  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
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014