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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00038311
First received: May 30, 2002
Last updated: May 3, 2007
Last verified: September 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Sarcoma
 Drug: PN-152,243)/PN-196,444
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 120
Study Start Date: September 2000
Study Completion Date: March 2003
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038311

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90067
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
Pfizer Investigational Site
Park Ridge, Illinois, United States, 60068
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19106
Pfizer Investigational Site
Radnor, Pennsylvania, United States, 19087
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00038311     History of Changes
Other Study ID Numbers: 444-ONC-0003-020
Study First Received: May 30, 2002
Last Updated: May 3, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thrombocytopenia
Sarcoma
Blood Platelet Disorders
Hematologic Diseases
 Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013