A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia

Myelogenous Leukemia, Acute Clinical Trial

Official title:
A Multi-Center, Open-Label, Phase 1/1b Study of Escalating Doses of RO5503781 Administered Orally as 1) a Single Agent, 2) In Combination With Cytarabine, or 3) With Cytarabine and Anthracycline and 4) Assessing PK and Safety of New Optimized Formulation of RO5503781 With Cytarabine in Patients With Acute Myelogenous Leukemia (AML)

Status Completed

Clinical Trial Summary

This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of RO5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized formulation of RO5503781 in combination with cytarabine will be assessed.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01773408
Study type	Interventional
Source	Hoffmann-La Roche
Contact
Status	Completed
Phase	Phase 1
Start date	February 2013
Completion date	June 2016

View Details

See also
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Completed	`NCT01635296` - A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia	Phase 1
Completed	`NCT01641250` - A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia	Phase 1
Completed	`NCT00130702` - Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia	Phase 2
Recruiting	`NCT04989335` - Bisantrene Combination for Resistant AML	Phase 2