CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0788 (clinicaltrials.gov NCT No: NCT01110473)
Title:A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-348 as monotherapy, and in combination with azacitidine, in Subjects with Advanced Hematologic Malignancies
Principal Investigator:Guillermo Garcia-Manero
Treatment Agent:ABT-348; Azacitidine
Study Status:Terminated
Study Description:The goal of this clinical research study is to find the highest tolerable dose
of ABT-348 that can be given alone or with Vidaza (azacitidine) to patients
with either leukemia or MDS. The safety of this drug or drug combination will
also be studied.

ABT-348 is designed to block proteins that cause cancer cells to grow and
multiply. ABT-348 is also designed to block the formation of new blood vessels
for the tumor. This may cause the cancer cells to die. This is the first study
using ABT-348 in humans.

Azacitidine is designed to block certain proteins in cancer cells whose job is
to stop the function of the tumor-fighting proteins. By blocking these
proteins, the tumor-fighting genes may be able to work better.

Hide details for General InformationGeneral Information

Disease Group:Leukemia
Phase of Study:Phase I
Treatment Agents:ABT-348
Azacitidine
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:none
Supported By:AbbVie
Return Visit:weekly
Home Care:NA


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Guillermo Garcia-Manero
Dept:Leukemia
For Clinical Trial Enrollment:713-745-3428
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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