| ClinicalTrials.gov Identifier |
| NCT05948475 |
| Institution Name |
| M.D. Anderson Cancer Center |
| Institution Address (Street) |
| 1515 Holcombe Blvd |
| Institution City |
| Houston |
| Institution State |
| Texas |
| Institution ZIP Code |
| 77030 |
| Institution Country |
| United States |
| Institution Phone |
| (713) 792-2121 |
| Institution Website |
| https://www.mdanderson.org |
| Additional Institutions |
| University of Virginia Cancer Center
1240 Lee St, Charlottesville, VA 22903
(434)443-3863
https://uvahealth.com/services/cancer
For a comprehensive list of all sites participating, please visit this study's clinicaltrials.gov page. |
| Principal Investigator |
| Dr. Milind Javle |
| Principal Investigator Phone |
| (713) 792-2828 |
| Principal Investigator Email |
| mjavle@mdanderson.org |
| Additional Principal Investigators |
| Dr. Paul Kunk
(434)443-3863
PRK5R@uvahealth.org |
| Study Coordinator |
| Chistine Fark |
| Study Coordinator Phone |
| (713) 732-9245 |
| Study Coordinator Email |
| cfark@mdanderson.org |
| Additional Study Coordinators |
| Kristen Harris
(434)297-5724
kah2gv@uvahealth.org |
| Study Overview |
| This is a randomized study to compare the effectiveness of tinengotinib against standard of care chemotherapy in patients who have received prior chemotherapy and one prior FGFR inhibitor (third line of treatment). Tinengotinib is an FGFR inhibitor, which is taken orally once a day. The control arm will be chemotherapy chosen by your physician. |
| Enrollment Information |
| Enrolling |
| Study Start Date |
| 20231116 |
| Study End Date |
| 20251116 |
| Study Purpose |
- Compare tinengotinib against physician's choice of chemotherapy in third line cholangiocarcinoma patients
|
| Inclusion Criteria |
- At least 18 years of age or order
- Have cholangiocarcinoma with unresectable or metastatic disease
- Have documentation of FGFR2 fusion/rearrangement
- Have received at least one prior line of chemotherapy, and exactly one line of prior FGFR inhibitor therapy (pemigatinib, futibatinib, infigratinib)
- Measurable disease per RECIST 1.1
|
| Exclusion Criteria |
- Have previous treatment with more than one FGFR inhibitor
- Have previous treatment with both FOLFOX and FOLFIRI
- Have uncontrolled hypertension
|
| Required Tests Prior to Study |
- Baseline lab assessments
- Physical examination
- Blood sample
- CT or MRI scan
- ECG exam and cardiac imaging (ECHO)
- Eye exam
|
| Potential Side Effects |
- High blood pressure
- Hand-foot syndrome (rash/numbness on palms of hands and soles of feet)
- Diarrhea, vomiting, nausea
- Dry mouth
- Swelling of lining of the mouth (stomatitis)
|
| Financial Assistance Available |
| Yes |
