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

Phase 3

Completed

• Conditions: Sarcoma

• Registration Number: NCT00038311
• 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 an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2002-05-30
• Study First Submitted QC: 2002-05-30
• Study First Posted: 2002-05-31
• Study Completion: 2003-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving AI (Adriamycin/Ifosfamide) chemotherapy

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 intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.

Secondary Outcome Measures

Name	Time	Method
Assess the safety of multiple IV doses of rhTPO.
Identify the effect of rhTPO on 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 were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles.
Determine the occurrence and clinical implications of any anti-TPO antibodies.
Assess the antitumor activity of AI chemotherapy.
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness.
Evaluate the impact of rhTPO prophylaxis on patient quality of life.
Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Houston, Texas, United States