Clinical Trials /

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

NCT02393248

Description:

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).

Related Conditions:
  • Endometrial Carcinoma
  • Gastric Carcinoma
  • Malignant Solid Tumor
  • Multiple Myeloma
  • Myeloproliferative Neoplasm
  • Squamous Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
  • Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

Clinical Trial IDs

  • ORG STUDY ID: INCB 54828-101
  • NCT ID: NCT02393248

Conditions

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

Interventions

DrugSynonymsArms
PemigatinibINCB054828Dose Escalation
Gemcitabine + CisplatinDose Escalation
PembrolizumabDose Escalation
DocetaxelDose Escalation
TrastuzumabDose Escalation
INCMGA00012Dose Escalation

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalOpen-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
  • Pemigatinib
  • Gemcitabine + Cisplatin
  • Pembrolizumab
  • Docetaxel
  • Trastuzumab
  • INCMGA00012

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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
Time Frame:from baseline through 21 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description: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
Measure: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
Safety Issue:
Description:The pharmacokinetic (PK) parameters of Cmax and Cmin will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.
Measure: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
Safety Issue:
Description:The pharmacokinetic (PK) parameters of Cmax and Cmin will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.
Measure: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
Safety Issue:
Description:The PK parameter of Tmax will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description:The PK parameter of Cl/F will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • alterations in FGF or FGFR
  • squamous non-small cell lung cancer
  • gastric cancer
  • urothelial cancer
  • endometrial cancer
  • multiple myeloma
  • MPN

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