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Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

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ClinicalTrials.gov Identifier: NCT03822117
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE January 28, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE May 29, 2019
Estimated Primary Completion Date December 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • Objective response rate (ORR) in Cohort A [ Time Frame: Up to approximately 6 months ]
    Defined as the proportion of participants in Cohort A who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO) as determined by an independent radiological review committee.
  • ORR in Cohort B [ Time Frame: Up to approximately 6 months ]
    Defined as the proportion of participants in Cohort B who achieve a CR or PR based on RECIST v1.1 or RANO as determined by an independent radiological review committee.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • Progression-free survival (PFS) [ Time Frame: Up to approximately 6 months ]
    Defined as the time from first dose until progressive disease (according to RECIST v1.1 or RANO and assessed by an independent central review) or death (whichever is first) in Cohorts A and B, respectively.
  • Duration of response (DOR) [ Time Frame: Up to approximately 6 months ]
    Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (according to RECIST v1.1 or RANO and assessed by an independent central review) or death (whichever is first) in Cohorts A and B, respectively.
  • Overall survival (OS) [ Time Frame: Up to approximately 6 months ]
    Defined as the time from first dose of study drug to death of any cause in Cohorts A and B, respectively.
  • Number of treatment-emergent adverse events [ Time Frame: Up to approximately 6 months ]
    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
  • Number of treatment-related adverse events. [ Time Frame: Up to approximately 6 months ]
    Adverse events considered to be treatment-related by the investigator.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
Official Title  ICMJE A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
Brief Summary The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. There is no difference in the treatment regimen between the cohorts.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor Malignancy
Intervention  ICMJE Drug: Pemigatinib
Pemigatinib administered orally once daily (QD).
Other Name: INCB054828
Study Arms  ICMJE Experimental: Pemigatinib
Cohort A (Solid tumor malignancies with FGFR1-3 in frame fusions). Cohort B (Solid tumor malignancies with activating point mutations in FGFR1-3) Cohort C (Solid tumor malignancies with any other FGFR1-3 point mutations and variants of unknown significance).
Intervention: Drug: Pemigatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 17, 2022
Estimated Primary Completion Date December 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable.
  • Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion.
  • Documentation of an FGFR1-3 gene mutation or translocation.
  • Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
  • Eastern Cooperative Oncology Group performance status 0 to 2.
  • Baseline archival tumor specimen (if < 12 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
  • Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  • Prior receipt of a selective FGFR inhibitor in the past 6 months.
  • Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib.
  • Cannot be a candidate for potentially curative surgery.
  • Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
  • Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment.
  • Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
  • Known additional malignancy that is progressing or requires active treatment.
  • History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
  • Clinically significant or uncontrolled cardiac disease.
  • Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed).
  • Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed).
  • Known HIV infection.
  • Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment.
  • Women who are pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Incyte Corporation Call Center(U.S) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com
Listed Location Countries  ICMJE Denmark,   France,   Italy,   Japan,   Korea, Republic of,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03822117
Other Study ID Numbers  ICMJE INCB 54828-207
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Luis Féliz, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP