Spots Global Cancer Trial Database for A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.
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Trial Identification
Brief Title: A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.
Official Title: An Open Label Study to Investigate the Maximum Tolerated Dose of RO5045337 in Patients With Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia (CML) in Blast Phase, or Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL / SCLL)
Study ID: NCT00623870
Conditions
Interventions
Study Description
Brief Summary: This study will determine the maximum tolerated dose of RO5045337 and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with hematologic neoplasms. A first cohort of patients will receive the starting dose of 20mg/m2/day orally, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. Different formulations of RO5045337 will be tested and the food effect evaluated. The anticipated time on study treatment is until disease progression or intolerable toxicity.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Duarte, California, United States
, New Brunswick, New Jersey, United States
, New York, New York, United States
, Houston, Texas, United States
, Toronto, Ontario, Canada
, Montreal, Quebec, Canada
, Bologna, Emilia-Romagna, Italy
, Roma, Lazio, Italy
, Glasgow, , United Kingdom
, Leeds, , United Kingdom
, Oxford, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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