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 (FIRST-308)
| ClinicalTrials.gov Identifier |
| NCT05948475 |
| Institution Name |
| University of Texas MD Anderson Cancer Center |
| Full Institution Address |
|
1515 Holcombe Blvd, Houston, TX 77030 Houston Texas 77030 United States |
| Institution Phone |
| (877) 632-6789 |
| Institution Website |
| https://www.mdanderson.org |
| Additional Institutions |
|
UCLA Medical Center 1-310-829-5471 The University of Chicago Hospitals The University of Chicago Medical Center UCMC 1-773-702-1530 Roswell Park Comprehensive Cancer Center 1-716-716-845-1300×1912 The University of Texas MD Anderson Cancer Center 1-713-794-1226 University of Virginia Cancer Center 1-434-297-5502 SCRI Oncology Partners 1-615-329-6862 Mount Sinai Comprehensive Cancer Center 1-305-535-3300 University of Texas Southwestern Medical Center – University Hospital Medical Oncology Clinic – Gastrointestinal Stanford Cancer Center Vanderbilt-Ingram Cancer Center Henry Ford Health 1-404-778-1900 Medical College of Wisconsin The University of Kansas Cancer Center 1-913-945-5052 Messino Cancer Center 1-828-212-7021 University of Minnesota- Masonic Cancer Center, M Health Fairview 1-612-624-0123 Texas Oncology-Sammons Cancer Center UMass Memorial Medical Center 1-774-622-500 Memorial Sloan Kettering Cancer Center 1-646-8884314 |
| Principal Investigator |
| Milind Javle |
| Principal Investigator Phone |
| 1-713-794-1226 |
| Principal Investigator Email |
| mjavle@mdanderson.org |
| Additional Principal Investigators |
|
Sahai, Vaibhav vsahai@med.umich.edu 1-734-647-8902 Mahipal, Amit amitmahipal@gmail.com Sadeghi, Saeed ssadeghi@mednet.ucla.edu 1-310-829-5471 Liao, Chih-Yi andyliao@medicine.bsd.uchicago.edu 1-773-702-1530 Fountzilas, Christos christos.fountzilas@roswellpark.org 1-716-716-845-1300×1912 Javle, Milind mjavle@mdanderson.org 1-713-794-1226 Kunk, Paul prk5r@hscmail.mcc.virginia.edu 1-434-297-5502 Pelster, Meredith Meredith.Pelster@sarahcannon.com 1-615-329-6862 Cusnir, Mike Gregory.Ruddell@msmc.com 1-305-535-3300 Hsieh, David david.hsieh@utsouthwestern.edu Goyal, Lipika lgoyal@stanford.edu Heumann, Thatcher thatcher.heumann@vumc.org Diab, Maria mdiab2@hfhs.org 1-404-778-1900 Phan, Alexandria aphan@mcw.edu Al-Rajabi, Raed ral-rajabi@kumc.edu 1-913-945-5052 Beardsley, Andrew andrew.beardsley@aoncology.com 1-828-212-7021 Greeno, Edward green048@umn.edu 1-612-624-0123 Kitchens, Benjamin benjamin.kitchens@usoncology.com Martin, Alexander alexander.martin3@umassmemorial.org 1-774-622-500 Harding, James hardinj1@mskcc.org 1-646-8884314 |
| Study Coordinator |
| Josephine Charles |
| Study Coordinator Phone |
| 713-750-1488 |
| Study Coordinator Email |
| JJCharles@mdanderson.org |
| Additional Study Coordinators |
|
Dippman, Dominique dippmand@med.umich.edu Becker, Laura beckerl@med.umich.edu Apale, Charmaine Charmaine.Apale2@UHhospitals.org Cruz, Adam Adam.Cruz@UHhospitals.org Jarrett, Andrea andrea.jasaleen.jarrett@uhhospitals.org Labbaf, Layla Layla.Labbaf@UHhospitals.org Ruiter, Adam adam.ruiter@uhhospitals.org Hunt, Alexia AlexiaHunt@mednet.ucla.edu Chang, Hang hchang@medicine.bsd.uchicago.edu Torre-Dorado, David ddelatorredorado@uchicago.edu Krasowski, Marian mariankrasowski@uchicago.edu Villamar, Dario dmv@uchicago.edu Berrueco, Luca Luca.Berrueco@bsd.uchicago.edu Bobb, Tameka tbobb@uchicago.edu Brooks, Amber xbu5595@uchicago.edu Desgardin, Aurelie adesgard@uchicago.edu El-Naggar, Ryan relnaggar@uchicago.edu Shaik, Afnan ashaik@uchicago.edu Zubeck, Mia mzubeck@uchicago.edu Scott, Koya koyas@uchicago.edu Woodfolk, Asha zxz4798@uchicago.edu Chatley, Sarah sarah.chatley@roswellpark.org Farrell, William William.Farrell@RoswellPark.org Blamowski, Jenna Jenna.Blamowski@RoswellPark.org Arena, Kathleen Kathleen.Arena@RoswellPark.org House, Alexandra alexandra.house@roswellpark.org Cox, Cimetra crcox@mdanderson.org Charles, Josephine JJCharles@mdanderson.org Harris, Kristen kah2gv@virginia.edu Flanagan, Cecilia cnr7zp@hscmail.mcc.virginia.edu James, Olivia omj5cg@hscmail.mcc.virginia.edu Neider, Amanda ALN4K@hscmail.mcc.virginia.edu George, Jessy jrg9n@uvahealth.org Du, Kevin kmd3pj@virginia.edu Brennan, Emma Emma.Brennan@scri.com King, Lauren lauren.king@scri.com Trull , Ethan ethan.trull@sscri.com Miller, Alydia 615-329-7274 Goya Balaguer, Evelyn Evelyn.goyabalaguer@msmc.com Lacombe , Ana Ana.Lacombe@msmc.com Brauchle, Yelida yelida.brauchle@msmc.com Hahn, Kaitlin kaitlin.hahn@msmc.com Welsh, Madeleine welshm@stanford.edu Puri, Shipra spuri1@hfhs.org Didevich, Dimitry ddidevi1@hfhs.org Heaviland, Haley hheavila@mcw.edu Molloy, Shannon smolloy@mcw.edu Dion, Barbara badion@mcw.edu Vallandingham, Ashley avallandingham@kumc.edu Cochran, Peggy pcochran@kumc.edu Duckett, Josh Josh.Duckett@aoncology.com Barrett, Chelsea Chelsea.Barrett@SarahCannon.com Soper, Stephanie ssoper@umn.edu Ford, Katreece katreece.ford@usoncology.com Agrilo, Alexandra Alexandra.Agrillo@umassmed.edu Malone, Paige Paige.Malone@umassmed.edu |
| Study Overview |
| This is a Phase 3 trial of the targeted therapy tinengotinib in cholangiocarcinoma. Tinengotinib is a new FGFR inhibitor which targets FGFR2 fusions and rearrangements, and has been shown to be effective after a patient receives another FGFR inhibitor such as pemigatinib. This study is randomized in a 2:1 ratio (tinengotinib:control), with the control arm being the chemotherapy thought to be the best fit for the patient. |
| Enrollment Information |
| Open |
| Study Start Date |
| 2023-12-01 |
| Study End Date |
| 2026-04-01 |
| Study Purpose |
|
+ To evaluate the effectiveness of tinengotinib in extending a patient's time on treatment without progressive disease + To evaluate the effectiveness of tinengotinib in extending a patient's life overall + To evaluate the safety of tinengotinib + To evaluate the quality of life of a patient receiving tinengotinib compared to standard of care therapy |
| Inclusion Criteria |
|
+ Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease. + Documentation of FGFR2 fusion/rearrangement gene status. Documentation from any point in disease course since the time of initial diagnosis is acceptable + Subjects must have received at least one line of prior chemotherapy and exactly one FDA-approved FGFR inhibitor (pemigatinib, infigratinib or futibatinib . Documentation of disease progression or recurrence following prior systemic chemotherapy and FGFR inhibitor therapy. Systemic adjuvant chemotherapy will be considered a line of treatment if there is documented disease progression or recurrence during or within 6 months of completing the therapy. + Radiographically measurable disease |
| Exclusion Criteria |
|
+ Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs. + Prior receipt of both FOLFOX and FOLFIRI chemotherapy regimens [+ v2.1]. + Have known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy + Have 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). |
| Financial Assistance Available |
| Yes |