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

PHASE1CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Myelogenous Leukemia, Acute
Interventions
DRUG

RO5503781 MBP

Participants will receive RO5503781 tablets daily (current formulation) containing microprecipitated bulk powder (MBP) at a starting dose of 400 milligrams (mg).

DRUG

RO5503781 SDP

Participants will receive RO5503781 tablets daily (new optimized formulation) containing spray-dried powder (SDP) at recommended dose(s) for development from Phase 1b to Phase 3.

DRUG

Idarubicin

Idarubicin will be administered as per standard clinical practice.

DRUG

Daunorubicin

Daunorubicin will be administered as per standard clinical practice.

DRUG

Cytarabine

Parts 2 and 4: Participants will receive cytarabine 1000 milligrams per meter squared (mg/m\^2) intravenous (IV) infusion daily. Part 3: Participants will receive cytarabine 100-200 mg/m\^2 IV infusion daily.

Trial Locations (12)

3000

Peter Maccallum Cancer Centre, Melbourne

10595

New York Medical College, Valhalla

13273

Institut J Paoli I Calmettes; Onco Hematologie 2, Marseille

19107

Thomas Jefferson University, Philadelphia

40138

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh, Bologna

78229

Cancer Therapy & Research Ctr; Dept Institute for Drug Development, San Antonio

90033

USC Norris Cancer Center, Los Angeles

M5G 2M9

University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto

H3T 1E2

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal

03080

Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul

05505

Asan Medical Center, Seoul

G12 0YN

The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit, Glasgow

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01773408 - A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia | Biotech Hunter | Biotech Hunter