Spots Global Cancer Trial Database for A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia
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Trial Identification
Brief Title: A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia
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)
Study ID: NCT01773408
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC Norris Cancer Center, Los Angeles, California, United States
New York Medical College, Valhalla, New York, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Cancer Therapy & Research Ctr; Dept Institute for Drug Development, San Antonio, Texas, United States
Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia
University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto, Ontario, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada
Institut J Paoli I Calmettes; Onco Hematologie 2, Marseille, , France
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh, Bologna, Emilia-Romagna, Italy
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit, Glasgow, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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