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Brief Title: Open-Label, Dose-Escalation Study of Pemigatinib 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)

INTRODUCTION

  • Org Study ID: INCB 54828-101
  • Secondary ID: N/A
  • NTC ID: NCT02393248
  • Sponsor: 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).

  • Overall Status
    Recruiting
  • Start Date
    February 27, 2015
  • Phase
    Phase 1, Phase 2
  • Study Type
    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 - Timeframe: 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 - Timeframe: 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

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

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: Luis Féliz, MD

Phone: 1-855-463-3463

Email: N/A

LOCATION

Facility Status Contact
Facility: Hematology Oncology Associates of the Tr
Port Saint Lucie, Florida 34952
United States
Status: Recruiting Contact: N/A
Facility: John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Status: Recruiting Contact: N/A
Facility: Mary Crowley Cancer Research Ctr
Dallas, Texas 75230
United States
Status: Recruiting Contact: N/A
Facility: Md Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: South Texas Accelerated Research Therapeutics
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A