Study of Regorafenib as a 3rd-line or Greater Treatment for Gastrointestinal Stromal Tumors (GIST) (GRID)

Study of Regorafenib as a 3rd-line or Greater Treatment for Gastrointestinal Stromal Tumors (GIST) (GRID)

Gastrointestinal Stromal Tumor

Ongoing, but not recruiting

3

Start Date 01/06/2011

Age of Trial (yrs) 13.3

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT + Block blood vessel growth

Specifically GIST and only GIST

14874, EudraCT: 2009-017957-37

Bayer

Bayer: clinical-trials-contact@bayerhealthcare.com Contact: For trial location information (Phone Menu Options '3' or '4'): +1 888 84 22937

Randomized

Oral

Note: Bayer issued a press release on April 3, 2012 stating that this trial had met its primary endpoint of a statistically significant progression-free survival (PFS). See links.

A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.

The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival Follow up Period.

Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive best supportive care which excludes any disease specific anti cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgery.

Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3 months (through month 6), and every 8 weeks until the end of treatment, or more frequently if clinically indicated. Tumor assessments include 'CT or MRI and will be performed until tumor progression is seen in a central radiology review.

Subjects receiving placebo who experience disease progression may be offered active treatment.

Subjects who experience progression during regorafenib treatment may continue open label treatment.

All subjects will enter the Survival Follow-up Period upon discontinuation of randomized study treatment.

For a complete list of sites that include those that are not yet recruiting, see the NCT link above to view the complete trial listing in clinicaltrials.gov.

Treatment with prior VEGF inhibitors (except Sutent), such as Nexavar (sorafenib) or Votrient (pazopanib) will exclude patients from participating in this trial.