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, 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 o

Trial Details

NCT ID

NCT03093116

Phase

PHASE1 / PHASE2

Sponsor

Turning Point Therapeutics, Inc.

Status

RECRUITING

Cancer Type

Non-Small Cell (NSCLC) Lung Cancer

Interventions

Oral repotrectinib (TPX-0005)

Locations (sample)

Duarte, California, United States|34.13945,-117.97729
Glendale, California, United States|34.14251,-118.25508
La Jolla, California, United States|32.84727,-117.2742
La Jolla, California, United States|32.84727,-117.2742
Long Beach, California, United States|33.76696,-118.18923

Key Eligibility Criteria

Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) (Stage IV, Americ…
ECOG PS 0-1.
Age ≥18 (or age ≥ 20 of age as required by local regulation).
Capability to swallow capsules intact (without chewing, crushing, or opening).

For full eligibility, visit ClinicalTrials.gov.

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