drugset / Trial / NCT01345214
A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 across multiple doses in patients with solid tumors and chemotherapy induced thrombocytopenia (CIT) scheduled to receive at least two cycles of myelosuppressive chemotherapy on Day 1 every 21 days at the same dosages and schedule in the study. The secondary objectives are to characterize the PK profiles of ONO-7746 and to explore the pharmacodynamic effect of ONO-7746 on CIT.
Timeline
- Start
- 2011-05
- Primary completion
- 2014-02
- Completion
- —
Outcome
Outcome not reported
Stopped (Enrollment): “The study was terminated due to slow accrual of subjects.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ONO-7746 | Unknown | 10 mg | — |
| Subject | ONO-7746 | Unknown | 20 mg | — |
| Subject | ONO-7746 | Unknown | 50 mg | — |
| Subject | ONO-7746 | Unknown | 100 mg | — |
| Subject | ONO-7746 | Unknown | 200 mg | — |
| Subject | ONO-7746 | Unknown | 300 mg | — |