Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00038311
Collaborator
(none)
120
6
29.9
20
0.7
Study Details
Study Description
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 |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
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
:
Sep 1, 2000
Actual Study Completion Date
:
Mar 1, 2003
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
13 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Los Angeles | California | United States | 90067 |
| 2 | Pfizer Investigational Site | Chicago | Illinois | United States | 60637 |
| 3 | Pfizer Investigational Site | Park Ridge | Illinois | United States | 60068 |
| 4 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19106 |
| 5 | Pfizer Investigational Site | Radnor | Pennsylvania | United States | 19087 |
| 6 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00038311
Other Study ID Numbers:
- 444-ONC-0003-020
First Posted:
May 31, 2002
Last Update Posted:
May 4, 2015
Last Verified:
Apr 1, 2015