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).
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | February 27, 2015 | Phase 1/Phase 2 | Interventional |
Primary Outcome 1 - Measure: Determination of the maximum tolerated dose of Pemigatinib as a monotherapy and in combination as measured by the number of participants with adverse events
Primary Outcome 1 - Time Frame: from baseline through 21 days
Primary Outcome 2 - Measure: Assess the pharmacodynamics of pemigatinib as a monotherapy and in combination as indicated by serum phosphorus level
Primary Outcome 2 - Time Frame: up to 30 days (+ 5 days) follow-up visit
Criteria:
Inclusion Criteria:
1. Male or female subjects, age 18 years or older on day of signing consent
2. 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
3. Has progressed after prior therapy and there is no further effective standard
anticancer therapy available (including subject refuses or is intolerant)
4. Life expectancy > 12 weeks
5. Eastern Cooperative Oncology Group (ECOG) performance status:
- Part 1: 0 or 1
- Part 2 and 3: 0, 1, or 2
Exclusion Criteria:
1. 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
2. Prior receipt of a selective FGFR inhibitor
3. History of a calcium/phosphate homeostasis disorder
4. History and/or current evidence of ectopic mineralization/calcification
5. Current evidence of corneal disorder/keratopathy
6. Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac
function parameters outside protocol-defined range
7. Prior radiotherapy within 2 weeks of study treatment
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Luis Féliz, MD
Role: Study Director
Affiliation: Incyte Corporation
Name: Incyte Call Center
Phone: 1-855-463-3463
Facility | Status | Contact |
---|---|---|
University of Alabama At Birmingham Comprehensive Cancer Center Birmingham, Alabama 35205 United States |
Recruiting | |
Cedars-Sinai Medical Center West Hollywood, California 90048 United States |
Completed | |
Yale Cancer Center New Haven, Connecticut 06510 United States |
Completed | |
Georgetown University Hospital Washington, District of Columbia 20007 United States |
Completed | |
Hematology Oncology Associates of the Tr Port Saint Lucie, Florida 34952 United States |
Recruiting | |
Emory University - Winship Cancer Institute Atlanta, Georgia 30322 United States |
Recruiting | |
University of Michigan Health System Ann Arbor, Michigan 48109 United States |
Completed | |
Washington University School of Medicine Saint Louis, Missouri 63110 United States |
Recruiting | |
John Theurer Cancer Center, Hackensack University Medical Center Hackensack, New Jersey 07601 United States |
Recruiting | |
Montefiore Medical Center Bronx, New York 10461 United States |
Recruiting | |
Northwell Health - Monter Cancer Center New Hyde Park, New York 11042 United States |
Recruiting | |
Duke University Medical Center Durham, North Carolina 27710 United States |
Recruiting | |
Ohio State University Medical Center Columbus, Ohio 43210 United States |
Recruiting | |
Signal Point Clinical Research Center Middletown, Ohio 45042 United States |
Completed | |
Greenville Health System Cancer Institute Greenville, South Carolina 29605 United States |
Completed | |
Mary Crowley Cancer Research Ctr Dallas, Texas 75230 United States |
Recruiting | |
Md Anderson Cancer Center Houston, Texas 77030 United States |
Recruiting | |
South Texas Accelerated Research Therapeutics San Antonio, Texas 78229 United States |
Recruiting | |
Baylor Scott & White Health Temple, Texas 76508 United States |
Completed | |
The Finsen Centre, National Hospital Copenhagen, 02100 Denmark |
Recruiting |