CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0693 (clinicaltrials.gov NCT No: NCT00785785)
Title:A randomized, open-label, multi-center phase III study to evaluate the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST)
Principal Investigator:Vinod Ravi
Treatment Agent:Imatinib; Nilotinib
Study Status:Closed
Study Description:The goal of the extension part of this study is to learn if patients with GIST,
who no longer respond to imatinib or nilotinib therapy that is given as part of
this study, would benefit from taking the other study drug they did not take.

In addition, the extension study now offers patients who received nilotinib in
the core study the possibility to be treated with imatinib prior to disease
progression.

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Disease Group:Sarcoma
Phase of Study:Phase III
Treatment Agents:Imatinib
Nilotinib
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:N/A
Supported By:Novartis
Return Visit:Main protocol-Pre-study visit. Day 1, day 8, day 28, then every 3 months.
Extension Study-visits will be every 3 months.
Home Care:Patients will be randomized to receive either Nilotinib or Imatinib. Patients
will self administer Nilotinib or Imatinib at home.


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Physician Name:Vinod Ravi
Dept:Sarcoma Medical Oncology
For Clinical Trial Enrollment:713-792-3626
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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