Spots Global Cancer Trial Database for A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia
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Trial Identification
Brief Title: A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia
Official Title: A Multi-center, Open Label, First in Human Phase I Dose Escalation Study of Single Agent RO5503781, a Small Molecule MDM2 Antagonist, Administered Orally in Patients With Advanced Malignancies, Except Leukemia
Study ID: NCT01462175
Conditions
Interventions
Study Description
Brief Summary: This multicenter, open label, dose-escalating study will evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of RO5503781, administered once daily (QD) or once weekly (QW) in participants with advanced malignancies except leukemia. Participants will receive multiple escalating oral doses in two different dosing schedules (Sch) until disease progression or unacceptable toxicity occurs.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Melbourne, Victoria, Australia
, Hamilton, Ontario, Canada
, Toronto, Ontario, Canada
, Montreal, Quebec, Canada
, Bordeaux, , France
, Lyon, , France
, Seoul, , Korea, Republic of
, Groningen, , Netherlands
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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