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

Pfizer120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

120

Conditions

Sarcoma

Interventions

PN-152,243)/PN-196,444DRUG

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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

Locations (6)

Pfizer Investigational Site

Los Angeles, California, United States

Pfizer Investigational Site

Chicago, Illinois, United States

Pfizer Investigational Site

Park Ridge, Illinois, United States

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Assess the safety of multiple IV doses of rhTPO.

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

Data from ClinicalTrials.gov

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