AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
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