A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
Purpose
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.
Condition
- Gastrointestinal Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable. - Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease. - Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.
Exclusion Criteria
- Known untreated or active central nervous system metastases. - Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded. - Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IDRX-42 (GSK6042981) |
|
|
|
Active Comparator Sunitinib |
|
Recruiting Locations
GSK Investigational Site
Phoenix, Arizona 85054
Phoenix, Arizona 85054
GSK Investigational Site
La Jolla, California 92093
La Jolla, California 92093
GSK Investigational Site
Los Angeles, California 90048
Los Angeles, California 90048
GSK Investigational Site
San Francisco, California 94158
San Francisco, California 94158
GSK Investigational Site
New Haven, Connecticut 06520
New Haven, Connecticut 06520
GSK Investigational Site
Jacksonville, Florida 41076
Jacksonville, Florida 41076
GSK Investigational Site
Miami, Florida 33136
Miami, Florida 33136
GSK Investigational Site
Orlando, Florida 32806
Orlando, Florida 32806
GSK Investigational Site
Tampa, Florida 33612
Tampa, Florida 33612
GSK Investigational Site
Iowa City, Iowa 52242
Iowa City, Iowa 52242
GSK Investigational Site
Overland Park, Kansas 66210
Overland Park, Kansas 66210
GSK Investigational Site
Boston, Massachusetts 02114-2696
Boston, Massachusetts 02114-2696
GSK Investigational Site
Boston, Massachusetts 02215
Boston, Massachusetts 02215
GSK Investigational Site
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
GSK Investigational Site
Rochester, Minnesota 55905
Rochester, Minnesota 55905
GSK Investigational Site
St Louis, Missouri 63108
St Louis, Missouri 63108
GSK Investigational Site
Omaha, Nebraska 68130
Omaha, Nebraska 68130
GSK Investigational Site
Lake Success, New York 11042
Lake Success, New York 11042
GSK Investigational Site
New York, New York 10032
New York, New York 10032
GSK Investigational Site
New York, New York 10065
New York, New York 10065
GSK Investigational Site
Rochester, New York 14642
Rochester, New York 14642
GSK Investigational Site
Durham, North Carolina 27710
Durham, North Carolina 27710
GSK Investigational Site
Columbus, Ohio 43210
Columbus, Ohio 43210
GSK Investigational Site
Portland, Oregon 97239
Portland, Oregon 97239
GSK Investigational Site
Philadelphia, Pennsylvania 19106
Philadelphia, Pennsylvania 19106
GSK Investigational Site
Philadelphia, Pennsylvania 19111
Philadelphia, Pennsylvania 19111
GSK Investigational Site
Spartanburg, South Carolina 29307
Spartanburg, South Carolina 29307
GSK Investigational Site
Knoxville, Tennessee 37920
Knoxville, Tennessee 37920
GSK Investigational Site
Dallas, Texas 75246
Dallas, Texas 75246
GSK Investigational Site
Houston, Texas 77030
Houston, Texas 77030
GSK Investigational Site
Santa Monica, Texas 90404
Santa Monica, Texas 90404
GSK Investigational Site
Salt Lake City, Utah 84106
Salt Lake City, Utah 84106
GSK Investigational Site
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
GSK Investigational Site
Seattle, Washington 98109
Seattle, Washington 98109
GSK Investigational Site
Tacoma, Washington 98405
Tacoma, Washington 98405
More Details
- Status
- Recruiting
- Sponsor
- GlaxoSmithKline