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

Status: Active

Description

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).

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: In review
Name Not Available

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Incyte Corporation

Trial IDs

Primary ID INCB 54828-101
Secondary IDs NCI-2015-00611
Clinicaltrials.gov ID NCT02393248