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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 this investigational drug in the prevention of thrombocytopenia in patients with solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support.
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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 two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia. |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the effect of rhTPO on the number of episodes of severe chemotherapy-induced thrombocytopenia(platelet count <15,000/mm3) and 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 | Berkeley | California | 94704 | 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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| Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia |
| Assess the likelihood that patients will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle |
| Assess the safety of multiple intravenous doses of rhTPO |
| Determine the occurrence and clinical implications of any anti-rhTPO antibodies |
| Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness |
| Evaluate the impact of rhTPO administration on patient quality of life |
| La Jolla |
| California |
| 92037 |
| United States |
| Pfizer Investigational Site | Los Angeles | California | 90033-0804 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90067 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70115 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Buenos Aires | Buenos Aires F.D. | 1114 | Argentina |
| Pfizer Investigational Site | Buenos Aires | Buenos Aires F.D. | 1406 | Argentina |
| Pfizer Investigational Site | Mexico City | Mexico City | 02990 | Mexico |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D013921 | Thrombocytopenia |
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
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