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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00038311
Recruitment Status : Completed
First Posted : May 31, 2002
Last Update Posted : May 4, 2015
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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))
Study Start Date : September 2000
Actual Study Completion Date : March 2003

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Identify the effect of rhTPO on the number of platelet transfusions.
  2. Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis.
  3. Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia.
  4. Assess the likelihood that patients were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles.
  5. Assess the safety of multiple IV doses of rhTPO.
  6. Determine the occurrence and clinical implications of any anti-TPO antibodies.
  7. Assess the antitumor activity of AI chemotherapy.
  8. Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness.
  9. Evaluate the impact of rhTPO prophylaxis on patient quality of life.
  10. Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration

Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038311


Locations
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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
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00038311    
Other Study ID Numbers: 444-ONC-0003-020
First Posted: May 31, 2002    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Sarcoma
Thrombocytopenia
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Blood Platelet Disorders
Hematologic Diseases