Condition: Locally Advanced Solid Tumors · Metastatic Solid Tumors · Sponsor: Turning Point Therapeutics, Inc.
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.
This description comes directly from the study's public registry record.
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| Local Institution - 2129 | Duarte, California, United States | Completed |
| Local Institution - 2120 | Glendale, California, United States | Completed |
| Local Institution - 2136 | La Jolla, California, United States | Withdrawn |
| Local Institution - 2114 | La Jolla, California, United States | Completed |
| Local Institution - 2121 | Long Beach, California, United States | Completed |
| Local Institution - 1001 | Orange, California, United States | Completed |
| Local Institution - 2101 | Orange, California, United States | Completed |
| St Joseph Heritage Healthcare | Santa Rosa, California, United States | Recruiting |
| Local Institution - 1003 | Aurora, Colorado, United States | Completed |
| Local Institution - 2103 | Aurora, Colorado, United States | Completed |
| Local Institution - 2106 | Washington D.C., District of Columbia, United States | Completed |
| Local Institution - 2110 | Washington D.C., District of Columbia, United States | Completed |
+ 153 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03093116