Trial Information

Summary: A Multi-Center, Open-Label Phase I Study of Single Agent RO5045337 Administered Orally 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)

You have been asked to participate in this research study because have one of the following advanced hematological malignancies that has not responded to treatment or that has no established effective treatment:
• 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)
The purpose of this study is to determine the safety and tolerability of RO5045337 (study drug). This compound demonstrated antitumor activity against a variety of cancer types in preclinical studies. The purpose of this research study is to determine the highest possible dose of the investigational drug RO5045337 that can be given before unmanageable side effects are seen. Repeated blood samples will be taken before and after the first dose of RO5045337 is given to study the levels of the drug that stay in the body over time. Your treatment on this study is expected to last a minimum of one cycle of treatment (28 days). If you are tolerating treatment and your medical condition is not getting worse, you will be able to receive additional cycles of treatment. After your treatment on this study is over, your medical condition will continue to be followed for 28 days.
 

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: October 6, 2008 at 3:02:28 PM