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 |
| [email protected] |
| Additional Principal Investigators |
|
Sahai, Vaibhav [email protected] 1-734-647-8902 Mahipal, Amit [email protected] Sadeghi, Saeed [email protected] 1-310-829-5471 Liao, Chih-Yi [email protected] 1-773-702-1530 Fountzilas, Christos [email protected] 1-716-716-845-1300×1912 Javle, Milind [email protected] 1-713-794-1226 Kunk, Paul [email protected] 1-434-297-5502 Pelster, Meredith [email protected] 1-615-329-6862 Cusnir, Mike [email protected] 1-305-535-3300 Hsieh, David [email protected] Goyal, Lipika [email protected] Heumann, Thatcher [email protected] Diab, Maria [email protected] 1-404-778-1900 Phan, Alexandria [email protected] Al-Rajabi, Raed [email protected] 1-913-945-5052 Beardsley, Andrew [email protected] 1-828-212-7021 Greeno, Edward [email protected] 1-612-624-0123 Kitchens, Benjamin [email protected] Martin, Alexander [email protected] 1-774-622-500 Harding, James [email protected] 1-646-8884314 |
| Study Coordinator |
| Josephine Charles |
| Study Coordinator Phone |
| 713-750-1488 |
| Study Coordinator Email |
| [email protected] |
| Additional Study Coordinators |
|
Dippman, Dominique [email protected] Becker, Laura [email protected] Apale, Charmaine [email protected] Cruz, Adam [email protected] Jarrett, Andrea [email protected] Labbaf, Layla [email protected] Ruiter, Adam [email protected] Hunt, Alexia [email protected] Chang, Hang [email protected] Torre-Dorado, David [email protected] Krasowski, Marian [email protected] Villamar, Dario [email protected] Berrueco, Luca [email protected] Bobb, Tameka [email protected] Brooks, Amber [email protected] Desgardin, Aurelie [email protected] El-Naggar, Ryan [email protected] Shaik, Afnan [email protected] Zubeck, Mia [email protected] Scott, Koya [email protected] Woodfolk, Asha [email protected] Chatley, Sarah [email protected] Farrell, William [email protected] Blamowski, Jenna [email protected] Arena, Kathleen [email protected] House, Alexandra [email protected] Cox, Cimetra [email protected] Charles, Josephine [email protected] Harris, Kristen [email protected] Flanagan, Cecilia [email protected] James, Olivia [email protected] Neider, Amanda [email protected] George, Jessy [email protected] Du, Kevin [email protected] Brennan, Emma [email protected] King, Lauren [email protected] Trull , Ethan [email protected] Miller, Alydia 615-329-7274 Goya Balaguer, Evelyn [email protected] Lacombe , Ana [email protected] Brauchle, Yelida [email protected] Hahn, Kaitlin [email protected] Welsh, Madeleine [email protected] Puri, Shipra [email protected] Didevich, Dimitry [email protected] Heaviland, Haley [email protected] Molloy, Shannon [email protected] Dion, Barbara [email protected] Vallandingham, Ashley [email protected] Cochran, Peggy [email protected] Duckett, Josh [email protected] Barrett, Chelsea [email protected] Soper, Stephanie [email protected] Ford, Katreece [email protected] Agrilo, Alexandra [email protected] Malone, Paige [email protected] |
| 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 |