CLINICAL TRIAL SUMMARY

MDACC Study No:2007-0408 (clinicaltrials.gov NCT No: NCT00623870)
Title: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)
Principal Investigator:Michael Andreeff
Treatment Agent:RO5045337
Study Status:Closed
Study Description:The goal of Phase 1 of this clinical research study is to find the highest
tolerable dose and best schedule of RO5045337 that can safely be given to
people with AML, ALL, CML, CLL, or SCLL.

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Disease Group:Leukemia; Lymphoma
Phase of Study:Phase I/Phase II
Treatment Agents:RO5045337
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:Hospitalization will be determined by the attending physician and/or the study
chair based on patient care needs. On Days -3/1 and 10 of Cycle 1: predose
procedures/samples and intermittent samples required up to 12 hours after
dosing.
Supported By:Hoffman-La Roche Inc., Protocol NO21279
Return Visit:Screen X
Cycle 1 D1, 2, 10, 11, 15, 22, 28
Cycle 2 D1, 2, 10, 11, 15, 22, 28
Cycle 3 D1, 10*, 11*, 15, 22, 28
Cycle 4 D1, 10*, 11*, nadir, 28
Cycle 5 D1, 10*, 11*, nadir, 28
Cycle 6 D1, 10*, 11*, nadir, 28
Off Study X
Relapse X
* IF QTc D. Red days outside or here.
Home Care:Oral meds may be taken at home except on those days when research blood draws
need to occur before/after dosing. Home physician must agree to follow patient
and labs done locally and communicate that information to us and labs provide
normal values.


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Physician Name:Michael Andreeff
Dept:Leukemia
For Clinical Trial Enrollment:713-792-7260
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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