FIRST-308

By CCF Clinical Trials | January 2, 2024
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
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
Posted in Clinical Trial, First Line Therapy, Targeted Therapy