Status:
COMPLETED
A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hematologic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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. ...
Eligibility Criteria
Inclusion
- Adult patients, \>=18 years of age
- 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
- Patients receiving any other agent or therapy to treat their malignancy
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00623870
Start Date
May 1 2008
End Date
November 1 2012
Last Update
November 2 2016
Active Locations (11)
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1
Duarte, California, United States, 91010
2
New Brunswick, New Jersey, United States, 08901
3
New York, New York, United States, 10065
4
Houston, Texas, United States, 77030