A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.
NCT ID: NCT00623870
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
116 participants
INTERVENTIONAL
2008-05-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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1
RO5045337
Multiple ascending doses
Interventions
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RO5045337
Multiple ascending doses
Eligibility Criteria
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Inclusion Criteria
* Acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia in blast phase, refractory chronic lymphocytic leukemia/small cell lymphocytic lymphoma
* Relapsed or refractory to approved therapies, or no viable alternative therapy available
* ECOG performance status of 0-2
Exclusion Criteria
* Pre-existing gastrointestinal disorders which may interfere with absorption of drugs
* Clinically significant cardiovascular disease
* Pregnant or lactating women
* HIV-positive patients receiving combination antiretroviral therapy
* Amendment J and onward for patients in the food effect evaluation and for all subsequent patients if dosing with a high fat/high calorie meal is found to be optimal: Patients with allergies to any ingredient in the defined liquid supplement and/or inability to tolerate a high fat/high calorie meal twice daily on scheduled RO5045337 dosing days
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Rome, Lazio, Italy
Glasgow, , United Kingdom
Leeds, , United Kingdom
Oxford, , United Kingdom
Countries
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Other Identifiers
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NO21279
Identifier Type: -
Identifier Source: org_study_id