A Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib

Official title

A Phase 2, Single-arm, Multicenter, Open-Label Study of Velzatinib (GSK6042981) in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib, Sunitinib, Regorafenib, and Pimitespib Therapies (StrateGIST J)

Overview

The goal of this study is to evaluate the study drug velzatinib (GSK6042981 / IDRX-42) to see whether velzatinib can shrink or control tumors and is safe and tolerated in Japan participants with gastrointestinal tumors (GIST) who progressed or were intolerant to standard therapies.

Interventions

• Drug Velzatinib
  Velzatinib will be administered.

Primary outcome measures

• Confirmed objective response rate (ORR) [Time frame: Up to 67 weeks]

Secondary outcome measures (9)

• Duration of response (DOR) [Time frame: Up to 156 weeks]
• Disease control rate for minimum 8-week period (DCR8) [Time frame: Up to 156 weeks]
• Progression free survival (PFS) [Time frame: Up to 156 weeks]
• Overall survival (OS) [Time frame: Up to 156 weeks]
• Confirmed ORR [Time frame: Up to 156 weeks]
• Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-F17 (EORTC-QLQ-F17) [Time frame: Baseline (Day 1) up to 156 weeks]
• Change from baseline in EQ-5D-5L score [Time frame: Baseline (Day 1) up to 156 weeks]
• Plasma concentrations of velzatinib [Time frame: Up to 156 weeks]
• Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), dose reductions and interruptions and discontinuation of study treatment due to toxicity by severity [Time frame: Up to 156 weeks]

Eligibility criteria

Inclusion criteria

• Histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
• Documented disease progression on or intolerance to imatinib, sunitinib, regorafenib, and pimitespib.
• Documented mutation status of KIT and/or PDGFRA.
• Tumor tissue must be available for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy.
• Is willing to use adequate contraception male and/or female participants.

Exclusion criteria

• Known untreated or active central nervous system metastases.
• Has significant, uncontrolled, or active cardiovascular disease.
• Participants with a known allergy or hypersensitivity to any component of velzatinib. 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.
• Prior treatment with ripretinib or other investigational agents that are currently under clinical development for GIST.
• Is pregnant or breastfeeding.
• Any condition or illness that, in the opinion of the Investigator, might compromise participant safety or interfere with the evaluation of the safety of the study treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07689201 · 309344

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗