metastatic and/or unresectable gastrointestinal stromal tumors (GIST)
Conditions
Brief summary
Phase 1: Nature, incidence, and severity of treatment-emergent adverse events (TEAEs) and DLTs., Phase 1b: (1) Safety: Nature, incidence, and severity of TEAEs and change from baseline in laboratory results (2) Efficacy: ORR per Response Evaluation Criteria in Solid Tumors version 1.1 modified for participants with GIST (mRECIST v1.1, (Demetri 2013), Appendix C) per Independent Review (IR)Investigator assessment, C-QTc Sub-Study: QTcF – concentration response analysis
Detailed description
Phase1: (1) Nature, incidence, and severity of TEAEs and change from baseline in laboratory results., Phase 1: (2) PK parameters of IDRX-42, Phase 1: (3) Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 modified for participants with GIST (mRECIST v1.1, (Demetri 2013), Appendix C) per Investigator assessment, Phase 1: (4) Duration of response (DOR) per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1: (5) Progression-free survival (PFS), per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1: (6) Time to response (TTR) per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1b: (7) DOR per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1b: (8) PFS per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1b: (9) Clinical benefit rate (CBR) per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1b: (10) TTR per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1b: (11) PK parameters of IDRX-42, Phase 1b: (12) Overall survival (OS), C-QTc Sub-Study: (1)QTcF (QT interval corrected by Fridericia's formula) at each post-dose time point and baseline (2)Change from baseline in the QTcF at each post-dose time point (3)Heart rate (HR), PR and QRS (QRS complex) interval at each post-dose time point and baseline (4)Change from baseline in HR, QRS, and PR-interval at each post-dose time point
Interventions
DRUGtablets 100mg
DRUGIDRX_100 mg Capsule
DRUGIDRX_20mg Capsule
Sponsors
Idrx Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Nature, incidence, and severity of treatment-emergent adverse events (TEAEs) and DLTs., Phase 1b: (1) Safety: Nature, incidence, and severity of TEAEs and change from baseline in laboratory results (2) Efficacy: ORR per Response Evaluation Criteria in Solid Tumors version 1.1 modified for participants with GIST (mRECIST v1.1, (Demetri 2013), Appendix C) per Independent Review (IR)Investigator assessment, C-QTc Sub-Study: QTcF – concentration response analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase1: (1) Nature, incidence, and severity of TEAEs and change from baseline in laboratory results., Phase 1: (2) PK parameters of IDRX-42, Phase 1: (3) Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 modified for participants with GIST (mRECIST v1.1, (Demetri 2013), Appendix C) per Investigator assessment, Phase 1: (4) Duration of response (DOR) per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1: (5) Progression-free survival (PFS), per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1: (6) Time to response (TTR) per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1b: (7) DOR per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1b: (8) PFS per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1b: (9) Clinical benefit rate (CBR) per mRECIST v1.1 (Demetri 2013) per Investigator assessment, Phase 1b: (10) TTR per mRECIST v1.1 (Demetri 2013) per Investigator assessment, P | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed