Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia

Phase 3

Completed

• Conditions: Neoplasms; Thrombocytopenia; Multiple Myeloma; Lymphoma, Malignant

• Registration Number: NCT00037791
• Lead Sponsor: Pfizer

Brief Summary

Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of this investigational drug in the prevention of thrombocytopenia in patients with solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2002-05-21
• Study First Submitted QC: 2002-05-21
• Study First Posted: 2002-05-22
• Study Completion: 2002-09
• Status Verified: 2006-09
• Last Update Submitted: 2006-11-08
• Last Update Posted: 2006-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patients must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support

Exclusion Criteria

• Patients must not have active bleeding (exclusions do apply) or history of platelet disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia.

Secondary Outcome Measures

Name	Time	Method
Identify the effect of rhTPO on the number of episodes of severe chemotherapy-induced thrombocytopenia(platelet count <15,000/mm3) and the number of platelet transfusions
Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO Prophylaxis
Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
Assess the likelihood that patients will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle
Assess the safety of multiple intravenous doses of rhTPO
Determine the occurrence and clinical implications of any anti-rhTPO antibodies
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
Evaluate the impact of rhTPO administration on patient quality of life

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇲🇽 Mexico City, DF, Mexico