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BRIEF TITLE: Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)

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


  • Org Study ID: INCB 54828-101
  • Secondary ID:
  • NCT ID: NCT02393248
  • NCT Alias:
  • Sponsor: Incyte Corporation - Industry
  • Source: Incyte Corporation

Brief 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).

Overal Status Start Date Phase Study Type
Recruiting Start Date: January 2015 Phase 1/Phase 2 Interventional

Primary Outcomes:

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

Condition:

  • Lung Cancer
  • Solid Tumor
  • Gastric Cancer
  • Urothelial Cancer
  • Endometrial Cancer
  • Multiple Myeloma
  • Myeloproliferative Neoplasms
  • Breast Cancer
  • Cholangiocarcinoma
  • UC
  • MPN

Eligibility

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

Official Information

Name: Luis Féliz, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: Incyte Call Center

Phone: 1-855-463-3463

Email:

Locations

Facility Status Contact
University of Alabama
Tuscaloosa, Alabama 35205
United States
Recruiting
Cedars Sinai
Los Angeles, California 90048
United States
Terminated
Yale Cancer Center
New Haven, Connecticut 06520
United States
Terminated
Georgetown University - Lombardi Comprehensive Cancer Center
Washington, District of Columbia 20007
United States
Terminated
Hematology - Oncology Associates of Treasure Coast
Port Saint Lucie, Florida 34952
United States
Recruiting
University of Michigan Health System
Ann Arbor, Michigan 48109
United States
Recruiting
Washington University
Saint Louis, Missouri 63110
United States
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Recruiting
Duke Cancer Institute
Durham, North Carolina 27710
United States
Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Recruiting
Signal Point Clinical Research Center
Middletown, Ohio 45042
United States
Terminated
Greenville Health System
Greenville, South Carolina 29605
United States
Recruiting
Mary Crowley Cancer Research Center
Dallas, Texas 75230
United States
Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229
United States
Recruiting
Onkologisk Klinik Rigshospitalet
Copenhagen, 2100
Denmark
Recruiting