AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin
Summary
The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim). Primary Objectives: 1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy 2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia 3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy Secondary Objective: 1\. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy
Timeline
- Start
- 2005-08
- Primary completion
- 2013-03
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Romiplostim | Peptide | 1 ug/kg | Subcutaneous |
| Subject | Romiplostim | Peptide | 3 ug/kg | Subcutaneous |
| Subject | Romiplostim | Peptide | 5 ug/kg | Subcutaneous |
| Subject | Romiplostim | Peptide | 10 ug/kg | Subcutaneous |
| Background | Carboplatin | Small molecule | — | — |
| Background | Doxorubicin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 90 mg/m2 | Intravenous |
| Background | Ifosfamide | Small molecule | 10000 mg/m2 | Intravenous |
| Background | Ifosfamide | Small molecule | 14000 mg/m2 | Intravenous |