Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

Part of paid clinical trials in Santa Monica, California.

Sponsor
TransThera Sciences (Nanjing), Inc.
Study ID
NCT05948475
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

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

Interventions

  • Tinengotinib 8 mg — DRUG
    Subjects randomized to receive tinengotinib will receive a starting dose of either 8 mg QD., self-administered orally QD in 28-day cycles.
  • Tinengotinib 10 mg — DRUG
    Subjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles.
  • Physician's Choice — DRUG
    For subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle.

Study Details

This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma

Key Dates

Start date
Dec 20, 2023
Status verified
May 2024
Primary completion
May 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tinengotinib 8 mg QD
    Tinengotinib will be administered in 28-day cycles.
  • Experimental: Tinengotinib 10 mg QD
    Tinengotinib will be administered in 28-day cycles.
  • Active Comparator: Physician's Choice
    Physician's Choice treatments include FOLFOX or FOLFIRI

Primary Outcome Measure

Part A: Incidence, duration, and severity of adverse events (AEs) [ Time Frame: Up to 30 days from study discontinuation ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterSanta MonicaCalifornia90401
Saeed Sadeghi (PRINCIPAL_INVESTIGATOR)
Stanford Cancer CenterStanfordCalifornia94305
Swetha Vadde
[email protected]
650-721-3343
Lipika Goyal (PRINCIPAL_INVESTIGATOR)
The University of Kansas Cancer CenterWestwood, Los AngelesCalifornia90024
Ashley Vallandingham
[email protected]
913-588-0593
Raed M Al-Rajabi (PRINCIPAL_INVESTIGATOR)
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140
Ana Lacombe
[email protected]
305-674-2625
Mike Cusnir (PRINCIPAL_INVESTIGATOR)
The University of Chicago HospitalsChicagoIllinois60601
Chih-Yi Liao (PRINCIPAL_INVESTIGATOR)
UMass Memorial Medical CenterWorcesterMassachusetts01655
Martin Alexander (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48103
Vaibhav Sahai (PRINCIPAL_INVESTIGATOR)
Henry FordDetroitMichigan48201
Maria Diab (PRINCIPAL_INVESTIGATOR)
University of Minnesota- Masonic Cancer Center, M Health FairviewMinneapolisMinnesota55455
Greeno Edward (PRINCIPAL_INVESTIGATOR)
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263
Jenna Blamowski
[email protected]
Sarah Chatley
[email protected]
716-845-4846
Christos Fountzilas (PRINCIPAL_INVESTIGATOR)
Messino Cancer CentersAshevilleNorth Carolina28806
Josh Duckett
[email protected]
828-212-7021
Andrew Beardsley (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Peggy Fowler
[email protected]
Amit Mahipal (PRINCIPAL_INVESTIGATOR)
Tennessee Oncology- NashvilleNashvilleTennessee37203
Emma Brennan
[email protected]
615-917-9153
Meredith S Pelster (PRINCIPAL_INVESTIGATOR)
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37203
Thatcher Heumann (PRINCIPAL_INVESTIGATOR)
Texas Oncology-Sammons Cancer CenterDallasTexas75246
Kitchens Benjamin (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75201
David Hsieh (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77002
Milind M Javle (PRINCIPAL_INVESTIGATOR)
University of Virginia Cancer CenterCharlottesvilleVirginia22908
Kristen Harris
[email protected]
434-297-5724
Kunk Paul (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53202
Alexandria T Phan (PRINCIPAL_INVESTIGATOR)

Find similar trials in Santa Monica, CA

By research site
UCLA Medical Center· Santa Monica, CAStanford Cancer Center· Stanford, CAThe University of Kansas Cancer Center· Westwood, Los Angeles, CAMount Sinai Comprehensive Cancer Center· Miami Beach, FLThe University of Chicago Hospitals· Chicago, ILUMass Memorial Medical Center· Worcester, MA

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