A Study of the Safety and Pharmacokinetics of RO6839921, An MDM2 Antagonist, in Patients With Advanced Cancers, Including Acute Myeloid Leukemia.

PHASE1CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

April 21, 2014

Primary Completion Date

May 7, 2018

Study Completion Date

May 7, 2018

Conditions
Neoplasms, Myelogenous Leukemia, Acute
Interventions
DRUG

RO6839921

Non-escalating IV doses given on Days 1-5 of Cycle 1.

DRUG

RO6839921

Escalating IV doses of RO6839921 in solid tumor patients. Dose escalation will be calculated using the new Continual Reassessment Method (nCRM). RO6839921 will be given on Days 1-5 of 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity or study discontinuation.

DRUG

RO6839921

Escalating IV doses of RO6839921 in AML patients. Escalation will follow an adapted rolling 6 design. Starting dose \</= dose inducing Grade 2 toxicity in patients with solid tumors. RO6839921 will be given on Days 1-5 of 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity or study discontinuation.

Trial Locations (5)

29425

Medical University of South Carolina; Hollings Cancer Center, Charleston

63110

Washington University, St Louis

80045

University of Colorado, Aurora

M5G 2M9

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

H3T 1E2

Jewish General Hospital / McGill University, Montreal

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02098967 - A Study of the Safety and Pharmacokinetics of RO6839921, An MDM2 Antagonist, in Patients With Advanced Cancers, Including Acute Myeloid Leukemia. | Biotech Hunter | Biotech Hunter