A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Part of paid clinical trials in Duarte, California.

Sponsor
Turning Point Therapeutics, Inc.
Study ID
NCT03093116
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Solid Tumors
  • Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 7, 2017
Status verified
May 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Repotrectinib (TPX-0005)
    Phase 1 Oral repotrectinib (TPX-0005): Phase 1a dose escalation, Phase 1b food-effect sub-study, and Phase 1c dose escalation with food, and Midazolam drug-drug interaction sub-study. Phase 2 Oral repotrectinib (TPX-0005): 6 distinct expansion cohorts * EXP-1: ROS1 TKI-naïve ROS1+ NSCLC * EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC * EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) * EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) * EXP-5: TRK TKI-naïve NTRK+ solid tumors * EXP-6: TRK TKI-pretreated NTRK+ solid tumors

Primary Outcome Measure

Dose limiting toxicities (DLTs) (Phase 1) [ Time Frame: Within 28 days of the first repotrectinib dose ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (49)

FacilityCityStateZIPSite coordinators
Local Institution - 2129DuarteCalifornia91010-
Local Institution - 2120GlendaleCalifornia91206-
Local Institution - 2114La JollaCalifornia92093-
Local Institution - 2136La JollaCalifornia92037-
Local Institution - 2121Long BeachCalifornia90813-
Local Institution - 1001OrangeCalifornia92868-
Local Institution - 2101OrangeCalifornia92868-
St Joseph Heritage HealthcareSanta RosaCalifornia95403
Ian Anderson, Site 2126
Local Institution - 1003AuroraColorado80045-
Local Institution - 2103AuroraColorado80045-
Local Institution - 2106Washington D.C.District of Columbia20007-
Local Institution - 2110Washington D.C.District of Columbia20016-
Memorial Healthcare SystemHollywoodFlorida33021
Luis Raez, Site 2128
954-265-4325
Local Institution - 2113TampaFlorida33612-
University Cancer and Blood CenterAthensGeorgia30607
PETROS NIKOLINAKOS, Site 2139
706-353-2990
Local Institution - 2134ColumbusGeorgia31904-
University of ChicagoChicagoIllinois60637
Christine Bestvina, Site 2125
773-702-4400
Local Institution - 2142PeoriaIllinois61615-
Local Institution - 2116New OrleansLouisiana70121
Site 2116
Local Institution - 2133BaltimoreMaryland21210-
Local Institution - 1004BostonMassachusetts02214-
Local Institution - 2131BostonMassachusetts02215-
Massachusetts General Hospital,BostonMassachusetts02114
Jessica Lin, Site 2104
617-724-4000
Local Institution - 2105Ann ArborMichigan48109-
Local Institution - 2111DetroitMichigan48201-
Local Institution - 2140DetroitMichigan48202-2608-
Local Institution - 2132Saint PaulMinnesota55101-
Local Institution - 2147BolivarMissouri65613-
Washington University Infusion Center PharmacySt LouisMissouri63110
Brian Van Tine, Site 2115
314-747-3096
Local Institution - 2122New BrunswickNew Jersey08901-
Local Institution - 1002New YorkNew York10065-
Local Institution - 2102New YorkNew York10065-
Local Institution - 2117New YorkNew York10016-
Local Institution - 2144GoldsboroNorth Carolina27534-
Local Institution - 2112CantonOhio44718-
Local Institution - 2143CincinnatiOhio45220-
Local Institution - 2109ClevelandOhio44195-
The Ohio State University Wexner Medical CenterColumbusOhio43210
Dwight Owen, Site 2123
614-293-6401
Local Institution - 2119ToledoOhio43614-
Local Institution - 2108PhiladelphiaPennsylvania19111-2497-
Baptist Memorial Hospital Baptist Cancer CenterMemphisTennessee38120
Philip Lammers, Site 2148
UT Southwestern Medical CenterDallasTexas75390
Syed Kazmi, Site 2130
214-648-5368
Local Institution - 2127HoustonTexas77030-
MD Anderson Cancer CenterHoustonTexas77030
George Blumenschein Jr, Site 2138
713-792-6363
Local Institution - 2146KingwoodTexas77339-
Local Institution - 2137FairfaxVirginia22031-
Local Institution - 2107SeattleWashington98109-
Local Institution - 2141TacomaWashington98405-
Local Institution - 2145AppletonWisconsin54911-

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Local Institution - 2129· Duarte, CALocal Institution - 2120· Glendale, CALocal Institution - 2114· La Jolla, CALocal Institution - 2136· La Jolla, CALocal Institution - 2121· Long Beach, CALocal Institution - 1001· Orange, CA

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