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NCT03093116 · ClinicalTrials.gov registry record · Phase 1
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
A Phase 1 study of Metastatic Solid Tumors and Locally Advanced Solid Tumors, sponsored by Turning Point Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT03093116 is a Phase 1 study of Metastatic Solid Tumors and Locally Advanced Solid Tumors that is actively recruiting participants, run by Turning Point Therapeutics. The registered enrollment target is 500 participants, above the 181-participant average among 20 other Metastatic Solid Tumors trials with a reported enrollment target (176% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT03093116, a Phase 1 study of Metastatic Solid Tumors and Locally Advanced Solid Tumors, is actively recruiting participants, sponsored by Turning Point Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
Conditions Studied
Interventions
- DRUG Oral repotrectinib (TPX-0005)
Study Locations (20)
California
- Local Institution - 2129 - Duarte
- Local Institution - 2120 - Glendale
- Local Institution - 2136 - La Jolla
- Local Institution - 2114 - La Jolla
- Local Institution - 2121 - Long Beach
- Local Institution - 2101 - Orange
- University of California Irvine Medical Center - Orange
- Local Institution - 2126 - Santa Rosa
Colorado
- Local Institution - 1003 - Aurora
- Local Institution - 2103 - Aurora
District of Columbia
- Local Institution - 2106 - Washington D.C.
- Local Institution - 2110 - Washington D.C.
Florida
- Local Institution - 2128 - Hollywood
- Local Institution - 2113 - Tampa
Georgia
- Local Institution - 2139 - Athens
- Local Institution - 2134 - Columbus
Illinois
- Local Institution - 2125 - Chicago
- Local Institution - 2142 - Peoria
Louisiana
- Local Institution - 2116 - New Orleans
Maryland
- Local Institution - 2133 - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2017-03-07 |
| Est. Completion | 2028-02-29 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03093116
The ClinicalTrials.gov registry entry for NCT03093116 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 181-participant average among 20 other Metastatic Solid Tumors trials with a reported enrollment target (176% higher). The listed sponsor is Turning Point Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Oral repotrectinib (TPX-0005) is the first listed.
NCT03093116 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Colorado, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03093116 about?
NCT03093116 is a clinical study titled "A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements". Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2...
What is the current status of trial NCT03093116?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 500 participants. The study started on 2017-03-07. Estimated completion is 2028-02-29.
What conditions does trial NCT03093116 study?
This clinical trial studies the following conditions: Metastatic Solid Tumors, Locally Advanced Solid Tumors.
What interventions are being tested in trial NCT03093116?
The interventions under investigation include: Oral repotrectinib (TPX-0005) (DRUG).
Who is sponsoring clinical trial NCT03093116?
This trial is sponsored by Turning Point Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03093116 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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