TerminatedPhase 1 / Phase 2NCT02393248
Official study title

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

Study summary

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPemigatinib and Gemcitabine

Plus 5 other study approaches.

Who it may be forLung Cancer · Solid Tumor

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 6, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?20 U.S. locations

Locations may change over time.

Who runs it?Incyte Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Incyte Corporation
Interventions being studied
Drug: Pemigatinib; Drug: Gemcitabine; Drug: Pembrolizumab; Drug: Docetaxel; Drug: Trastuzumab; Drug: Retifanlimab; Drug: Cisplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama At Birmingham Comprehensive Cancer CenterBirmingham, Alabama
  • Cedars-Sinai Medical CenterWest Hollywood, California
  • Yale Cancer CenterNew Haven, Connecticut
  • Georgetown University HospitalWashington D.C., District of Columbia
  • Hematology Oncology Associates of the TrPort Saint Lucie, Florida
  • Emory University - Winship Cancer InstituteAtlanta, Georgia
  • University of Michigan Health SystemAnn Arbor, Michigan
  • Washington University School of MedicineSt Louis, Missouri
  • John Theurer Cancer Center, Hackensack University Medical CenterHackensack, New Jersey
  • Northwell Health - Monter Cancer CenterNew Hyde Park, New York
  • Montefiore Medical CenterThe Bronx, New York
  • Duke University Medical CenterDurham, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 6, 2023. Always confirm current availability with the study team.

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