Trials / Terminated
TerminatedNCT01345214
A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
An Open-label, Multiple-Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Ono Pharma USA Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-7746 | 10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2014-02-01
- First posted
- 2011-04-29
- Last updated
- 2014-04-01
Locations
14 sites across 3 countries: United States, Russia, South Korea
Source: ClinicalTrials.gov record NCT01345214. Inclusion in this directory is not an endorsement.