GIST Clinical Trial
Official title:
A Phase II Randomized Multicentre Study Evaluating the Efficacy of Pazopanib+Best Supportive Care (BSC) Versus BSC Alone in Metastatic and/or Locally Advanced Unresectable GIST, Resistant to Imatinib and Sunitinib
The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST) resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.
Complete resection, with or without associated anticancer therapy, is the standard treatment
of GIST. Even though the prognosis of advanced GIST has been tremendously improved by the
introduction of tyrosine kinase inhibitors (TKI-imatinib, sunitinib...), the vast majority
of patients will develop secondary resistance to these agents. The therapeutic options for
patients with advanced GIST with resistance (or intolerance) to imatinib and sunitinib
remain very limited. Some new molecules are currently being evaluated in patients with
metastatic or locally advanced - imatinib-resistant disease. Nilotinib, for instance, has
been evaluated in phase I/II trials and compassionate use programs with a median
progression-free survival (PFS) close to 3 months and a median overall survival close to 8.5
months. A phase III trial comparing nilotinib vs. best supportive care (BSC) +/- imatinib or
sunitinib (investigators choice) has just been completed and results are pending. Another
molecule, Sorafenib, has been evaluated in 4th line treatment in compassionate use studies,
with a median PFS close to 5 months and a median overall survival of 10-13 months. There are
currently no recognized standard options after failure of 2nd line treatment, and the
recently updated guidelines from the NCCN or ESMO (2009) suggest the possible reintroduction
of TKI in an attempt to control the progression of sensitive cell clones.
Pazopanib is a broad spectrum TKI targeting KIT, PDGFR and VEGFR which has been tested in
phase II trials in advanced sarcomas and has demonstrated promising antitumor activity.
Whether pazopanib would be useful in patients with GIST is not known.
In the present study, we propose to analyze the antitumor activity of pazopanib in patients
with GIST refractory to imatinib and sunitinib. The drug will be tested against BSC in a
randomized setting, with possible crossing-over to the no-treatment arm.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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