A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib Therapy (StrateGIST 3)
Summary
The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.
Arms & interventions
- DrugIDRX-42
IDRX-42 will be administered.
- DrugSunitinib
Sunitinib will be administered.
Outcome measures
Primary
Progression-Free Survival (PFS)
PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 130 weeks
Secondary
Overall Survival (OS)
Time frame: Up to approximately 261 weeks
Progression-Free Survival (PFS)
Time frame: Up to approximately 261 weeks
Confirmed Overall Objective Response Rate (ORR)
Time frame: Up to approximately 261 weeks
Time to Response (TTR)
Time frame: Up to approximately 261 weeks
Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2)
Time frame: Up to approximately 261 weeks
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)
Time frame: Baseline (Day 1) and up to approximately 261 weeks
Time To Confirmed Deterioration (TTCD)
Time frame: Up to approximately 261 weeks
Plasma concentrations of IDRX-42 (GSK6042981)
Time frame: Up to approximately 261 weeks
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to approximately 261 weeks
Number of Participants with TEAEs and SAEs by severity
Time frame: Up to approximately 261 weeks
Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity
Time frame: Up to approximately 261 weeks
Number of participants with symptomatic adverse events (AEs), by severity, as measured by the Patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Up to approximately 261 weeks
Number of participants with bothersome AEs/tolerability as measured by the Functional Assessment of Cancer Therapy - General (FACT-GP5)
Time frame: Up to approximately 261 weeks
Eligibility criteria
Study locations (36)
GSK Investigational Site
Phoenix, Arizona, 85054
GSK Investigational Site
La Jolla, California, 92093
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
San Francisco, California, 94158
GSK Investigational Site
New Haven, Connecticut, 06520
GSK Investigational Site
Jacksonville, Florida, 41076
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Tampa, Florida, 33612
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Overland Park, Kansas, 66210
GSK Investigational Site
Boston, Massachusetts, 02114-2696
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Ann Arbor, Michigan, 48109
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
St Louis, Missouri, 63108
GSK Investigational Site
Omaha, Nebraska, 68130
GSK Investigational Site
Lake Success, New York, 11042
GSK Investigational Site
New York, New York, 10032
GSK Investigational Site
New York, New York, 10065
GSK Investigational Site
Rochester, New York, 14642
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Columbus, Ohio, 43210
GSK Investigational Site
Portland, Oregon, 97239
GSK Investigational Site
Philadelphia, Pennsylvania, 19106
GSK Investigational Site
Philadelphia, Pennsylvania, 19111
GSK Investigational Site
Pittsburgh, Pennsylvania, 15232
GSK Investigational Site
Spartanburg, South Carolina, 29307
GSK Investigational Site
Knoxville, Tennessee, 37920
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Santa Monica, Texas, 90404
GSK Investigational Site
Salt Lake City, Utah, 84106
GSK Investigational Site
Charlottesville, Virginia, 22903
GSK Investigational Site
Seattle, Washington, 98109
GSK Investigational Site
Tacoma, Washington, 98405