Spots Global Cancer Trial Database for A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
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Trial Identification
Brief Title: A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
Official Title: Open Label, Multicenter, Dose Escalation Phase 1a/b Study of RO5429083, Administered as Intravenous Infusion Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML).
Study ID: NCT01641250
Conditions
Study Description
Brief Summary: This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time on study treatment is 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
, Marseille, , France
, Nantes, , France
, Paris, , France
, Toulouse, , France
, Aachen, , Germany
, Hamburg, , Germany
, Ulm, , Germany
, Bologna, Emilia-Romagna, Italy
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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