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A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)

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ClinicalTrials.gov Identifier: NCT03656536
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

Condition or disease Intervention/treatment Phase
Unresectable Cholangiocarcinoma Metastatic Cholangiocarcinoma Drug: Pemigatinib Drug: Gemcitabine Drug: Cisplatin Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023


Arm Intervention/treatment
Experimental: Pemigatinib Drug: Pemigatinib
Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).
Other Name: INCB054828

Active Comparator: Gemcitabine + Cisplatin
Participants who experience disease progression while receiving gemcitabine + cisplatin or during the follow-up period and before starting a new anticancer therapy will be eligible allowed to cross over and receive pemigatinib.
Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.

Drug: Cisplatin
Cisplatin 25 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to approximately 12 months ]
    Defined as the time from date of randomization until date of disease progression (according to Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 and assessed by an independent central reviewer (ICR)) or death, whichever occurs first.


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to approximately 12 months ]
    Defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by an ICR.

  2. Overall survival [ Time Frame: Up to approximately 12 months ]
    Defined as the time from date of randomization until death due to any cause.

  3. Duration of response [ Time Frame: Up to approximately 12 months ]
    Defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurs first.

  4. Disease control rate [ Time Frame: Up to approximately 12 months ]
    Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease (SD) per RECIST v1.1 as assessed by an ICR.

  5. Number of treatment-emergent adverse events [ Time Frame: Up to approximately 12 months ]
    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

  6. Quality of Life impact as assessed by the EQ-5D-3L questionnaire [ Time Frame: Up to 12 months ]
  7. Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire [ Time Frame: Up to 12 months ]
  8. Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

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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:

  • Male and female participants at least 18 years of age at the time of signing the informed consent form (ICF); a legally minor participant from Japan needs written parental consent.
  • Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual).
  • Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria.
  • Eastern Cooperative Oncology Group performance status 0 to 1.
  • Documented FGFR2 rearrangement.
  • Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  • Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment).
  • Child-Pugh B and C.
  • Toxicities related to prior therapy(ies) must be Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ Grade 1 at the time of screening.
  • Concurrent anticancer therapy, other than the therapies being tested in this study.
  • Must not be a candidate for potentially curative surgery.
  • Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, retinal detachment) as confirmed by ophthalmologic examination.
  • Radiation therapy administered within 4 weeks of enrollment/randomization/first dose of study treatment.
  • Known central nervous system (CNS) metastases or history of uncontrolled seizures.
  • Known additional malignancy that is progressing or requires active treatment (exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy).
  • Laboratory values at screening outside the protocol-defined range.
  • History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues, such as the skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
  • Gastrointestinal conditions/disorders that may raise gastric and/or small intestinal pH that could interfere with absorption, metabolism, or excretion of pemigatinib.
  • Clinically significant or uncontrolled cardiac disease.
  • History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful.
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment within 2 weeks prior to enrollment.
  • Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. Note: Moderate CYP3A4 inhibitors are not prohibited
  • Known hypersensitivity or severe reaction to pemigatinib, gemcitabine, cisplatin, or their excipients.
  • Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.

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): NCT03656536


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 globalmedinfo@incyte.com

Locations
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United States, Florida
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Study Coordinator    305-674-2625      
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Study Coordinator    773-702-7763      
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Study Coordinator    410-502-5327      
United States, New Jersey
Summit Medical Group PA Recruiting
Florham Park, New Jersey, United States, 07932
Contact: Study Coordinator    973-436-1755      
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Study Coordinator    503-494-3175      
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Study Coordinator    215-214-1660      
United States, South Carolina
Greenville Health System Cancer Institute Recruiting
Greenville, South Carolina, United States, 29605
Contact: Study Coordinator    864-699-5731      
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Study Coordinator    206-287-5671      
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Luis Féliz, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03656536     History of Changes
Other Study ID Numbers: INCB 54828-302
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
Cholangiocarcinoma
fibroblast growth factor receptor inhibitor
FGFR
FGFR rearrangement

Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs