GIST Clinical Trial
Official title:
Phase 2 Trial of Ponatinib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor Following Failure of Prior Tyrosine Kinase Inhibitor Therapy
The purpose of this study is to evaluate the efficacy and safety of ponatinib in participants with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure of prior tyrosine kinase inhibitor (TKI) therapy.
This is a non-randomized, open label, multi-center phase 2 study to evaluate the efficacy and
safety of ponatinib in participants with metastatic and/or unresectable GIST after failure of
prior TKI therapy. Participants whose tumors have an activating mutation in exon 11 of
cellular KIT (KIT) will be enrolled into Cohort A. Participants whose tumors have other
activating mutations will be enrolled into in Cohort B.
The primary objective is to assess clinical benefit in participants with KIT exon 11-mutant
GIST (Cohort A) defined as clinical benefit rate (CBR), which is the composite of complete
response (CR), partial response (PR) and stable disease (SD) lasting greater than or equal to
(>=) 16 weeks per modified response evaluation criteria in solid tumors (RECIST 1.1) as a
measure of disease control. The secondary objective is to assess clinical benefit in
participants with GIST that lacks an activating KIT exon 11 mutation (Cohort B) and in the
total participant population. The efficacy assessments are tumor response using RECIST
Version 1.1, modified for GIST and assessment of progression-free survival (PFS) and overall
survival (OS). The safety assessments include routine physical and laboratory evaluations,
electrocardiograms (ECGs), echocardiograms (ECHOs), and adverse event (AE) monitoring. Other
assessments include optional 18F fluorodeoxyglucose positron emission tomography (FDG-PET);
optional pre- and post-treatment tumor biopsy for pharmacodynamic studies; and
pharmacokinetics (PK). It is estimated that accrual will be complete within 1 year; the total
estimated duration of the study is 3 years.
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