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))
Phase 3
13 Years
N/A
13 Years
N/A
Not Enrolling
Both
Sarcoma
Both
Sarcoma
Trial Information
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))
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
444-ONC-0003-020
NCT ID:
NCT00038311
Start Date:
September 2000
Completion Date:
March 2003
Related Keywords:
- Sarcoma
- Thrombocytopenia
- Sarcoma
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
