drugset / Trial / NCT01345214

A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia

NCT01345214 ↗

Phase 1 Terminated 17 enrolled Ono Pharma USA Inc
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

EvaluationDrugModalityDoseRoute
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 —

Indications