Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
Stopped early · Phase 2
Conditions studied: Solid Tumor Malignancy
In brief
The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.
Key facts
- Study ID
- NCT03822117
- Run by
- Incyte Corporation
- People needed
- 111
- Starts
- 2019-10-17
- Expected to finish
- 2022-03-29
- Last updated by the study team
- 2025-11-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable.
- Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion.
- Documentation of an FGFR1-3 gene mutation or translocation.
- Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
- Eastern Cooperative Oncology Group performance status 0 to 2.
- Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
- Willingness to avoid pregnancy or fathering children.
You may not qualify if…
- Prior receipt of a selective FGFR inhibitor in the past 6 months.
- Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib.
- Cannot be a candidate for potentially curative surgery.
- Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
- Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment.
- Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
- Known additional malignancy that is progressing or requires active treatment.
- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
- Clinically significant or uncontrolled cardiac disease.
- Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed).
- Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed).
- Known HIV infection.
- Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment.
- Women who are pregnant or breastfeeding.
Where it is running
- Mayo Clinic Hospital — Phoenix, Arizona, United States
- The University of Arizona Cancer Center — Tucson, Arizona, United States
- Chao Family Comprehensive Cancer Center University of California, Irvine — Orange, California, United States
- Stanford Cancer Center — Palo Alto, California, United States
- John Wayne Cancer Institute — Santa Monica, California, United States
- St. Joseph Heritage Healthcare — Santa Rosa, California, United States
- Florida Cancer Specialists & Research Institute — Fort Myers, Florida, United States
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States
- Florida Cancer Specialists — St. Petersburg, Florida, United States
- Florida Cancer Specialists — Tallahassee, Florida, United States
- Florida Cancer Specialists — West Palm Beach, Florida, United States
- Illinois Cancer Specialists — Arlington Heights, Illinois, United States
- Edward H Kaplan & Associates — Skokie, Illinois, United States
- Carle Cancer Center — Urbana, Illinois, United States
- Cancer Treatment Centers of America — Zion, Illinois, United States
- Indiana University Health - Arnett Cancer Care — Lafayette, Indiana, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Kansas Cancer Center — Westwood, Kansas, United States
- Ochsner Clinic — New Orleans, Louisiana, United States
- Central Maine Medical Center — Lewiston, Maine, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Umass Memorial Medical Center, Inc. — Worcester, Massachusetts, United States
- Mayo Clinic Rochester — Rochester, Minnesota, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Cancer Treatment Centers of America — Goodyear, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.