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)

Conditions

Gastrointestinal Neoplasms

Brief summary

Progression-Free Survival (PFS)

Detailed description

Overall Survival (OS), Progression-Free Survival (PFS), as assessed by the investigator, Confirmed Overall Objective Response Rate (ORR), Time to Response (TTR), Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2), Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30), Time To Confirmed Deterioration (TTCD), Plasma concentrations of IDRX-42 (GSK6042981), Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), Number of Participants with TEAEs and SAEs by severity, Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity, 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), Number of participants with bothersome AEs/tolerability as measured by the Functional Assessment of Cancer Therapy - General (FACT-GP5)

Related papers

No related papers found yet.

Interventions

DRUGSunitinib Malate

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS)	—

Secondary

Measure	Time frame
Overall Survival (OS), Progression-Free Survival (PFS), as assessed by the investigator, Confirmed Overall Objective Response Rate (ORR), Time to Response (TTR), Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2), Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30), Time To Confirmed Deterioration (TTCD), Plasma concentrations of IDRX-42 (GSK6042981), Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), Number of Participants with TEAEs and SAEs by severity, Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity, 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), Number of participa	—

Measure

Time frame

Overall Survival (OS), Progression-Free Survival (PFS), as assessed by the investigator, Confirmed Overall Objective Response Rate (ORR), Time to Response (TTR), Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2), Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30), Time To Confirmed Deterioration (TTCD), Plasma concentrations of IDRX-42 (GSK6042981), Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), Number of Participants with TEAEs and SAEs by severity, Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity, 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), Number of participa

—

Outcome results

None listed