Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
- Conditions
- Cholangiocarcinoma
- Interventions
- Registration Number
- NCT05948475
- Lead Sponsor
- TransThera Sciences (Nanjing), Inc.
- Brief Summary
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
- Detailed Description
Approximately 200 subjects will be enrolled. Eligible subjects will be randomized in a 2:2:1 ratio to receive tinengotinib 8 mg QD, tinengotinib 10 mg QD or Physician's Choice in Part A; and eligible subjects will be randomized in a 2:1 ratio to receive the recommended Part B dose or selected dose or Physician's Choice in Part B.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.
- Documentation of FGFR2 fusion/rearrangement gene status
- Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.
- Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs.
- Subjects with known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy. Subjects with asymptomatic brain/CNS metastases or treated brain/CNS metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment.
- Subjects with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, including those that have previously undergone potentially curative therapy.
- Subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs) of prior therapy.
- Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval.
- Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy.
- Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tinengotinib 10 mg QD Tinengotinib 10 mg Tinengotinib will be administered in 28-day cycles. Physician's Choice Physician's Choice Physician's Choice treatments include FOLFOX or FOLFIRI Tinengotinib 8 mg QD Tinengotinib 8 mg Tinengotinib will be administered in 28-day cycles.
- Primary Outcome Measures
Name Time Method Part A: Incidence, duration, and severity of adverse events (AEs) Up to 30 days from study discontinuation As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).
Part B: PFS by BICR From first study drug administration until the date of first documented progression assessed by BICR or date of death from any cause, whichever came first, assessed up to 24 months Progression-free survival (PFS) by BICR: PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or date of death due to any cause, whichever is earlier.
- Secondary Outcome Measures
Name Time Method Part B: Objective Response Rate (ORR) by BICR and by Investigator: Through study completion, an average of 9 months. The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Part B: Duration of Response (DOR) by BICR and by Investigator Through study completion, an average of 9 months. Duration of response for CR or PR based on RECIST version 1.1.
Part A: ORR by Investigator Through study completion, an average of 9 months. ORR:objective response rate (ORR), the proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Part B:Overall Survival (OS) From first study drug administration until the date of death from any cause, assessed up to 24 months. OS is defined as the time from date of randomization to date of death of any cause.
Part B: PFS by Investigators per RECIST v1.1. From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Part A: DOR by Investigator Through study completion, an average of 9 months. Duration of response for CR or PR based on RECIST version 1.1.
Trial Locations
- Locations (86)
UCLA Medical Center
🇺🇸Santa Monica, California, United States
The University of Chicago Hospitals
🇺🇸Chicago, Illinois, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
The University of Kansas Cancer Center
🇺🇸Westwood, California, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Hopital Franco-Britannique - Fondation Cognacq-Jay
🇫🇷Levallois-Perret, France
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Ludwig-Maximilians-Universität München Kum
🇩🇪München, Germany
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeollanam-do, Korea, Republic of
Yonsei University Health System - Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Universitari Vall d´Hebron
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, Spain
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
🇮🇹Siena, Italy
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
Messino Cancer Centers
🇺🇸Asheville, North Carolina, United States
Texas Oncology-Sammons Cancer Center
🇺🇸Dallas, Texas, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Universitair Ziekenhuis Antwerpen
🇧🇪Antwerp, Belgium
Landesklinikum Wiener Neustadt
🇦🇹Wiener Neustadt, Austria
Institut Sainte Catherine - Institut du Cancer Avignon Provence
🇫🇷Avignon, France
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Centre Hospitalier Régional Universitaire de Besançon
🇫🇷Besancon, France
Hopital Beaujon
🇫🇷Clichy, France
Centre Hospitalier Universitaire de Montpellier
🇫🇷Montpellier, France
Clinique de la Sauvegarde
🇫🇷Lyon, France
Hopital Saint Antoine
🇫🇷Paris, France
Institut de Cancerologie Gustave Roussy
🇫🇷Villejuif, France
Krebszentrum Reutlingen
🇩🇪Baden, Germany
Krankenhaus Nordwest gGmbH
🇩🇪Frankfurt, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT)
🇩🇪Heidelberg, Germany
Clinica Oncologica, Ospedali Riuniti Umberto 1
🇮🇹Ancona, Italy
Candiolo Cancer Institute - FPO IRCCS
🇮🇹Candiolo, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola, Italy
ASST Grande Ospedale Metropolitano Niguard
🇮🇹Milano, Italy
Istituto Europeo di Oncologia IRCCS
🇮🇹Milan, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli
🇮🇹Napoli, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
🇮🇹Napoli, Italy
Azienda Ospedaliera Universitaria di Parma
🇮🇹Parma, Italy
Humanitas Research Hospital
🇮🇹Rozzano, Italy
AOUI Verona - Ospedale Borgo Roma
🇮🇹Verona, Italy
CHA Bundang Medical Center
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju-si, Gyeongsangnam-do, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Amsterdam UMC, location AMC
🇳🇱Amsterdam, Netherlands
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
🇵🇱Warszawa, Poland
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
🇵🇹Lisbon, Portugal
Fundação Champalimaud
🇵🇹Lisboa, Portugal
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario Reina Sofa
🇪🇸Cordoba, Spain
HM Hospital Universitario Madrid Sanchinarro - CIOCC
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario 12 de octubre
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
🇨🇳Kaohsiung, Taiwan
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
The Christie NHS Foundation Trust - Christie Hospital
🇬🇧Manchester, United Kingdom
Royal Marsden Hospital NHS
🇬🇧London, United Kingdom
UCG-1st floor central
🇬🇧London, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Stanford Cancer Center
🇺🇸Stanford, California, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Ordensklinikum Linz GmbH
🇦🇹Linz, Austria
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford
🇺🇸Detroit, Michigan, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Minnesota- Masonic Cancer Center, M Health Fairview
🇺🇸Minneapolis, Minnesota, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology- Nashville
🇺🇸Nashville, Tennessee, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States