Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

Stopped early · Phase 1/Phase 2

Conditions studied: Lung Cancer, Solid Tumor, Gastric Cancer, Urothelial Cancer, Endometrial Cancer, Multiple Myeloma, Myeloproliferative Neoplasms, Breast Cancer, Cholangiocarcinoma, UC, MPN

In brief

The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).

Key facts

Study ID

NCT02393248

Run by

Incyte Corporation

People needed

201

Starts

2015-02-27

Expected to finish

2021-12-17

Last updated by the study team

2023-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects, age 18 years or older on day of signing consent
• Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
• Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
• Life expectancy > 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status:
• Part 1: 0 or 1
• Part 2 and 3: 0, 1, or 2

You may not qualify if…

• Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
• Prior receipt of a selective FGFR inhibitor
• History of a calcium/phosphate homeostasis disorder
• History and/or current evidence of ectopic mineralization/calcification
• Current evidence of corneal disorder/keratopathy
• Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
• Prior radiotherapy within 2 weeks of study treatment

Where it is running

• University of Alabama At Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — West Hollywood, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Hematology Oncology Associates of the Tr — Port Saint Lucie, Florida, United States
• Emory University - Winship Cancer Institute — Atlanta, Georgia, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• John Theurer Cancer Center, Hackensack University Medical Center — Hackensack, New Jersey, United States
• Northwell Health - Monter Cancer Center — New Hyde Park, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Ohio State University - Wexner Medical Center — Columbus, Ohio, United States
• Signal Point Clinical Research Center — Middletown, Ohio, United States
• Greenville Health System Cancer Institute — Greenville, South Carolina, United States
• Mary Crowley Cancer Research Ctr — Dallas, Texas, United States
• Md Anderson Cancer Center — Houston, Texas, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• Baylor Scott & White Health — Temple, Texas, United States
• The Finsen Centre National Hospital — Copenhagen, Denmark

Full record on ClinicalTrials.gov

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