FIRST-308

Study Name
	FIRST-308
ClinicalTrials.gov Identifier (if applicable)
	NCT05948475
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Targeted Therapy
Study Center
Institution Name
	M.D. Anderson Cancer Center
Institution Address
	1515 Holcombe Blvd
City
	Houston
State
	Texas
Zip Code
	77030
Country
	United States
Phone
	(713) 792-2121
Website
	https://www.mdanderson.org
List additional Institutions (include address, phone number, and website)
	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.
Study Contacts
Principal Investigator
	Dr. Milind Javle
P.I. Phone
	(713) 792-2828
P.I. Email
	mjavle@mdanderson.org
List additional Principal Investigators (include phone number and email)
	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
List additional Study Coordinators (include phone number and email)
	Kristen Harris (434)297-5724 kah2gv@uvahealth.org
OVERVIEW – in layman’s terms (150 words max)
	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
	Enrolling
Study Start Date
	11/16/2023
Estimated Completion Date
	11/16/2025
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	Compare tinengotinib against physician’s choice of chemotherapy in third line cholangiocarcinoma patients
Inclusion Criteria – Patients Must:
	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 – Patients Must NOT:
	Have previous treatment with more than one FGFR inhibitor Have previous treatment with both FOLFOX and FOLFIRI Have uncontrolled hypertension
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	Baseline lab assessments Physical examination Blood sample CT or MRI scan ECG exam and cardiac imaging (ECHO) Eye exam
POTENTIAL SIDE-EFFECTS – in layman’s terms
	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 is available to participants for travel, lodging, etc.
	Yes