Previously untreated metastatic and/or unresectable gastrointestinal stromal tumors (GIST)
Conditions
Interventions
Velzatinib arm, imatinib arm
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Is at least 18 years of age at the time of signing the informed consent form (ICF). Has histologically or cytologically confirmed that is metastatic and/or surgically unresectable. Has not received prior systemic therapy for metastatic and/or surgically unresectable GIST. Tumor tissue must be provided to the central laboratory. Tumor tissues may be archival (preferred) or obtained from a fresh biopsy acquired for standard of care. At least 1 target lesion. ECOG Performance Status <-1. Adequate organ function as defined in the protocol. All participants must use adequate contraception. Is capable of giving signed informed consent.
Exclusion criteria
Exclusion criteria: Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months, with specified exceptions. Has any clinically significant gastrointestinal abnormalities that may alter drug absorption (e.g., malabsorption syndrome or major gastrointestinal resection). Has had any major surgery within 14 days prior to first dose of study treatment or participants who have not fully recovered from surgery. Has any history of prior allogeneic/autologous bone marrow transplant or other solid organ transplant. Has known allergy or hypersensitivity to velzatinib or imatinib. Has a history of clinically significant or uncontrolled cardiovascular disease within 6 months prior to enrollment. Has untreated or progressive brain/CNS metastases. Has ongoing toxicities from prior therapy that have not recovered to <-Grade 1 or to the baseline preceding prior therapy (except specified conditions). Has any active renal condition. Has any serious or unstable medical or psychiatric condition that could interfere with study participation. Has received radiotherapy within 14 days prior to first dose of study treatment. Has a positive drug or alcohol screening assessment. Has a known HIV infection meeting protocol-defined exclusion criteria. Is pregnant or breastfeeding. ALT, bilirubin or QTc findings meeting protocol-defined exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Confirmed Objective Response Rate (ORR) as assessed by BICR - Overall Survival (OS) - Confirmed ORR by investigator assessment - PFS by investigator assessment - Time from initial study randomization to second disease progression or death (PFS2) - Duration of Response (DOR) - Time to Response (TTR) - Time to Second Subsequent Therapy (TSST) - Safety and tolerability including incidence and severity of TEAEs and SAEs, dose reductions, interruptions, and discontinuations - Plasma concentrations of velzatinib - Health-related quality of life assessed by EORTC QLQ-C30 - Symptomatic adverse events by severity by PRO-CTCAE - Adverse events / tolerability assessed by FACT-GP5 | — |
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed