A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | May 2008 |
| End Date: | November 2012 |
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)
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
5
sites
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