Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02393248
Recruitment Status : Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE March 19, 2015
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE February 27, 2015
Actual Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
  • Determination of the maximum tolerated dose of INCB054828 as measured by the number of participants with adverse events [ Time Frame: from baseline through 21 days ]
  • Assess the pharmacodynamics of INCB054828 as indicated by serum phosphorus level [ Time Frame: up to 30 days (+ 5 days) follow-up visit ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
  • Preliminary efficacy as assessed by Overall Response Rate (ORR) of INCB054828 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
  • Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of INCB054828 [ 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 INCB054828 using standard noncompartmental PK methods.
  • Minimum observed plasma concentration (Cmin) during the dosing interval of INCB054828 [ 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 INCB054828 using standard noncompartmental PK methods.
  • Time to maximum plasma concentration (Tmax) of INCB054828 [ 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 INCB054828 using standard noncompartmental PK methods.
  • Area under the single-dose plasma concentration-time curve (AUC0-t) of INCB054828 [ 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.
  • Oral dose clearance (Cl/F) of INCB054828 [ 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 INCB054828 using standard noncompartmental PK methods.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
Official Title  ICMJE A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Solid Tumor
  • Gastric Cancer
  • Urothelial Cancer
  • Endometrial Cancer
  • Multiple Myeloma
  • Myeloproliferative Neoplasms
  • Breast Cancer
  • Cholangiocarcinoma
  • UC
  • MPN
Intervention  ICMJE
  • Drug: Pemigatinib
    Other Name: INCB054828
  • Drug: Gemcitabine + Cisplatin
  • Drug: Pembrolizumab
  • Drug: Docetaxel
  • Drug: Trastuzumab
  • Drug: INCMGA00012
Study Arms  ICMJE 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
Interventions:
  • Drug: Pemigatinib
  • Drug: Gemcitabine + Cisplatin
  • Drug: Pembrolizumab
  • Drug: Docetaxel
  • Drug: Trastuzumab
  • Drug: INCMGA00012
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 2, 2021)
201
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2015)
70
Estimated Study Completion Date  ICMJE May 30, 2021
Actual Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02393248
Other Study ID Numbers  ICMJE INCB 54828-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 2021

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