drugset / Trial / NCT00283439
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma
Parallel-groupOpen-labelSupportive care
Summary
The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.
Timeline
- Start
- 2005-10
- Primary completion
- 2008-05
- Completion
- 2008-09
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Romiplostim 100 µg vs Romiplostim 1000 µg; p = 0.9654; Satterhwaite t-test; note: One-sided test NCT00283439 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Romiplostim | Peptide | 100 ug | — |
| Subject | Romiplostim | Peptide | 300 ug | — |
| Subject | Romiplostim | Peptide | 700 ug | — |
| Subject | Romiplostim | Peptide | 1000 ug | — |