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

Overview

The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in patients with advanced malignancies.

SparkCures ID 851
Trial Phase Phase 1/2
Enrollment 195 Patients
Treatments
  • Cisplatin
  • Docetaxel
  • Gemcitabine
  • INCB054828
  • INCMGA00012
  • Pembrolizumab
  • Pemigatinib
  • Trastuzumab
Trial Sponsors
  • Incyte Corporation
NCT Identifier

NCT02393248

CLOSED

This trial has completed.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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