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

Sarcoma Clinical Trial

Official title:

Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia Administered to Patients With High-Risk Sarcoma Receiving Intensive Chemotherapy (Adriamycin and Ifosfamide (AI))

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038311
• Other study ID #: 444-ONC-0003-020
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2002
• Last updated: April 30, 2015
• Start date: September 2000
• Est. completion date: March 2003

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sarcoma
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• PN-152,243)/PN-196,444

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Park Ridge	Illinois
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Radnor	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.
Secondary	Identify the effect of rhTPO on the number of platelet transfusions.
Secondary	Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis.
Secondary	Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia.
Secondary	Assess the likelihood that patients were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles.
Secondary	Assess the safety of multiple IV doses of rhTPO.
Secondary	Determine the occurrence and clinical implications of any anti-TPO antibodies.
Secondary	Assess the antitumor activity of AI chemotherapy.
Secondary	Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness.
Secondary	Evaluate the impact of rhTPO prophylaxis on patient quality of life.
Secondary	Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration

External Links

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