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ClinicalTrials.gov Identifier
NCT05948475
Institution Name
M.D. Anderson Cancer Center
Full Institution Address
1515 Holcombe Blvd

Houston
Texas
77030
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