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

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ClinicalTrials.gov Identifier: NCT02393248
Recruitment Status : Recruiting
First Posted : March 19, 2015
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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).

Condition or disease Intervention/treatment Phase
Lung Cancer Solid Tumor Gastric Cancer Urothelial Cancer Endometrial Cancer Multiple Myeloma Myeloproliferative Neoplasms Breast Cancer Cholangiocarcinoma UC MPN Drug: Pemigatinib Drug: Gemcitabine + Cisplatin Drug: Pembrolizumab Drug: Docetaxel Drug: Trastuzumab Drug: INCMGA00012 Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)
Actual Study Start Date : February 27, 2015
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : May 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Pemigatinib

Arms and Interventions
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Arm Intervention/treatment
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
 Drug: Pemigatinib
Other Name: INCB054828

Drug: Gemcitabine + Cisplatin
Drug: Pembrolizumab
Drug: Docetaxel
Drug: Trastuzumab
Drug: INCMGA00012


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


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:

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393248


Contacts
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Contact: Incyte Call Center 1-855-463-3463

Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Luis Féliz, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02393248    
Other Study ID Numbers: INCB 54828-101
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Keywords provided by Incyte Corporation:
alterations in FGF or FGFR
squamous non-small cell lung cancer
gastric cancer
urothelial cancer
 endometrial cancer
multiple myeloma
MPN
Additional relevant MeSH terms:
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Multiple Myeloma
Stomach Neoplasms
Endometrial Neoplasms
Cholangiocarcinoma
Myeloproliferative Disorders
Neoplasms by Site
Neoplasms
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
 Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Adenocarcinoma
Carcinoma