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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PN-152,243)/PN-196,444 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia. |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the effect of rhTPO on the number of platelet transfusions. | ||
| Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis. | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Los Angeles | California | 90067 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 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 |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Pfizer Investigational Site | Park Ridge | Illinois | 60068 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19106 | United States |
| Pfizer Investigational Site | Radnor | Pennsylvania | 19087 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |