Ph II CABOGIST in GIST

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT02216578
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Gastrointestinal Stromal Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The study is a multi-center, multi-national, open label, single arm Phase II study of single-agent cabozantinib. The objective of the study is to assess the safety and activity of cabozantinib in patients with metastatic GIST who have previously progressed on imatinib and sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase inhibitors. Patient will receive cabozantinib until they experience no further benefit from the treatment, becoming intolerant to the drug or wishing to discontinue the treatment. Treatment beyond RECIST 1.1 progression is allowed in patients deriving clinical benefit upon investigator's discretion, provided no other criteria for treatment withdrawal are met.

Key Dates

Start date
Feb 2, 2017
Status verified
Jul 2021
Primary completion
May 20, 2019
Completion
Feb 23, 2021

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cabozantinib
    cabozantinib 60 mg oral daily

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: at 12 weeks ]

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