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

January 4, 2022 updated by: Incyte Corporation

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 2
  • Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 02100
        • The Finsen Centre National Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • California
      • West Hollywood, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Florida
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Tr
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University - Winship Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center, Hackensack University Medical Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • New Hyde Park, New York, United States, 11042
        • Northwell Health - Monter Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University - Wexner Medical Center
      • Middletown, Ohio, United States, 45042
        • Signal Point Clinical Research Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research Ctr
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation

Open-label dose escalation with an accelerated titration design based on observing each dose level for a period of 21 days.

Dose Expansion

Combination therapy:

  • Gemcitabine + Cisplatin + Pemigatinib
  • Pembrolizumab + Pemigatinib
  • Docetaxel + Pemigatinib
  • Trastuzumab + Pemigatinib
  • INCMGA00012 + Pemigatinib
Drug: Docetaxel
Drug: Pembrolizumab
Drug: Trastuzumab
Drug: Pemigatinib
Other Names:
  • INCB054828
Drug: Gemcitabine + Cisplatin
Drug: INCMGA00012

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of the maximum tolerated dose of Pemigatinib as a monotherapy and in combination as measured by the number of participants with adverse events
Time Frame: from baseline through 21 days
from baseline through 21 days
Assess the pharmacodynamics of pemigatinib as a monotherapy and in combination as indicated by serum phosphorus level
Time Frame: up to 30 days (+ 5 days) follow-up visit
up to 30 days (+ 5 days) follow-up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary efficacy as assessed by Overall Response Rate (ORR) of Pemigatinib as monotherapy and in combination in subjects with measurable disease
Time Frame: Day 15 of every third cycle (± 2 days) while subjects are on study
Tumor response rates in those subjects with measurable disease as determined by investigator assessment of response using RECIST (Response Evaluation Criteria in Solid Tumor) criteria
Day 15 of every third cycle (± 2 days) while subjects are on study
Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy and in combination
Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15
The pharmacokinetic (PK) parameters of Cmax and Cmin will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.
Cycle 1 Day 1, Day 2, Day 8 and Day 15
Minimum observed plasma concentration (Cmin) during the dosing interval of Pemigatinib as monotherapy and in combination
Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15
The pharmacokinetic (PK) parameters of Cmax and Cmin will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.
Cycle 1 Day 1, Day 2, Day 8 and Day 15
Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy and in combination
Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15
The PK parameter of Tmax will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.
Cycle 1 Day 1, Day 2, Day 8 and Day 15
Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy and in combination
Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, calculated by the linear trapezoidal rule for increasing concentrations and the log trapezoidal rule for decreasing concentrations.
Cycle 1 Day 1, Day 2, Day 8 and Day 15
Oral dose clearance (Cl/F) of Pemigatinib as monotherapy and in combination
Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15
The PK parameter of Cl/F will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.
Cycle 1 Day 1, Day 2, Day 8 and Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Luis Féliz, MD, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2015

Primary Completion (Actual)

December 17, 2021

Study Completion (Actual)

December 17, 2021

Study Registration Dates

First Submitted

January 30, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 54828-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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