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

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ClinicalTrials.gov Identifier: NCT00038311
Recruitment Status : Completed
First Posted : May 31, 2002
Last Update Posted : May 4, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 30, 2002
First Posted Date  ICMJE May 31, 2002
Last Update Posted Date May 4, 2015
Study Start Date  ICMJE September 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2006)
To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Official Title  ICMJE 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))
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Sarcoma
Intervention  ICMJE Drug: PN-152,243)/PN-196,444
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 28, 2006)
120
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00038311
Other Study ID Numbers  ICMJE 444-ONC-0003-020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP