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出境医 / 临床实验 / Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)

Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)

Study Description
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 tumors harboring activating FGFR mutations or translocations.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors FGFR Mutations FGFR Translocations Drug: Pemigatinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 [excluding kinase domain]) but there is no difference in the treatment regimen between the cohorts.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208)
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : April 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Pemigatinib Drug: Pemigatinib
Pemigatinib administered orally once daily.
Other Name: INCB054828
Outcome Measures
Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to approximately 6 months ]
    Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to approximately 6 months ]
    Defined as the time from first dose until progressive disease (per RECIST v1.1 or Response Assessment in Neuro-Oncology [RANO]) or death (whichever is first) in each cohort.

  2. 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 (per RECIST v1.1 or RANO) or death (whichever is first) in each cohort.

  3. Disease control rate (DCR) [ Time Frame: Up to approximately 6 months ]
    Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease per RECIST v1.1 or RANO.

  4. 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 each cohort.

  5. Number of treatment-related adverse events [ Time Frame: Up to approximately 6 months ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV) or is surgically unresectable.
  • Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).
  • Documentation of an FGFR1-3 gene mutation or translocation.
  • Objective disease progression after at least 1 prior therapy.
  • Not eligible or able to participate in any other Incyte-sponsored clinical trial.

Exclusion Criteria:

  • Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
  • Prior receipt of a selective FGFR inhibitor.
  • Current evidence of clinically significant corneal or retinal disorder.
  • History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
Contacts and Locations

Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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United States, California
Compassionate Cancer Care Medical Group Recruiting
Fountain Valley, California, United States, 92708
United States, Florida
Ocala Oncology Center Recruiting
Ocala, Florida, United States, 34474
United States, Hawaii
Hawaii Cancer Care Recruiting
Honolulu, Hawaii, United States, 96813
United States, Illinois
Illinois Cancer Care Recruiting
Peoria, Illinois, United States, 61615
United States, Maryland
FMH James M Stockman Cancer Institute Recruiting
Frederick, Maryland, United States, 21702
United States, New Jersey
New Jersey Cancer Care and Blood Disorders Recruiting
Belleville, New Jersey, United States, 07109
United States, Ohio
TriHealth Recruiting
Cincinnati, Ohio, United States, 45220
United States, South Dakota
Sanford Cancer Center Recruiting
Sioux Falls, South Dakota, United States, 51704
United States, Texas
Mary Crowley Cancer Center Recruiting
Dallas, Texas, United States, 75230
Oncology Consultants Recruiting
Houston, Texas, United States, 77030
United States, Utah
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Incyte Medical Monitor Incyte Corporation
Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date June 24, 2020
Actual Study Start Date  ICMJE October 31, 2019
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019) 		Objective response rate (ORR) [ Time Frame: Up to approximately 6 months ]
Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Progression-free survival (PFS) [ Time Frame: Up to approximately 6 months ]
    Defined as the time from first dose until progressive disease (per RECIST v1.1 or Response Assessment in Neuro-Oncology [RANO]) or death (whichever is first) in each cohort.
  • 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 (per RECIST v1.1 or RANO) or death (whichever is first) in each cohort.
  • Disease control rate (DCR) [ Time Frame: Up to approximately 6 months ]
    Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease per RECIST v1.1 or RANO.
  • 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 each cohort.
  • Number of treatment-related adverse events [ Time Frame: Up to approximately 6 months ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
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 Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
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 Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208)
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 tumors harboring activating FGFR mutations or translocations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 [excluding kinase domain]) but there is no difference in the treatment regimen between the cohorts.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced or Metastatic Solid Tumors
  • FGFR Mutations
  • FGFR Translocations
Intervention  ICMJE Drug: Pemigatinib
Pemigatinib administered orally once daily.
Other Name: INCB054828
Study Arms  ICMJE Experimental: Pemigatinib
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: June 28, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date October 31, 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 (Stage IIIB or IV) or is surgically unresectable.
  • Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).
  • Documentation of an FGFR1-3 gene mutation or translocation.
  • Objective disease progression after at least 1 prior therapy.
  • Not eligible or able to participate in any other Incyte-sponsored clinical trial.

Exclusion Criteria:

  • Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
  • Prior receipt of a selective FGFR inhibitor.
  • Current evidence of clinically significant corneal or retinal disorder.
  • History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
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 (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003623
Other Study ID Numbers  ICMJE INCB 54828-MA-TA-208
Has Data Monitoring Committee No
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: Yes
Plan Description:

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Incyte Medical Monitor Incyte Corporation
PRS Account Incyte Corporation
Verification Date June 2020

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

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