Trial record 1 of 1 for:
Fight-302
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03656536 |
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Recruitment Status :
Recruiting
First Posted : September 3, 2018
Last Update Posted : August 9, 2019
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Sponsor:
Incyte Corporation
Information provided by (Responsible Party):
Incyte Corporation
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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 ...
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Cholangiocarcinoma
| 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 |
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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.
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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 :
- 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 :
- 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.
- Overall survival [ Time Frame: Up to approximately 12 months ]Defined as the time from date of randomization until death due to any cause.
- 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.
- 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.
- 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.
- Quality of Life impact as assessed by the EQ-5D-3L questionnaire [ Time Frame: Up to 12 months ]
- 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 ]
- Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire [ Time Frame: Up to 12 months ]
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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.
- Participant is 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
| 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 |
Hide Study Locations
Locations
| United States, Arizona | |
| Mayo Clinic Arizona | Recruiting |
| Phoenix, Arizona, United States, 85054 | |
| Contact: Study Coordinator 480-342-6029 | |
| United States, California | |
| UC Irvine Medical Center | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Study Coordinator 714-456-6210 | |
| United States, Florida | |
| Mayo Clinic Florida | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Study Coordinator 904-953-3814 | |
| 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, Kansas | |
| The University of Kansas Cancer Center | Recruiting |
| Westwood, Kansas, United States, 66205 | |
| Contact: Study Coordinator 913-588-1886 | |
| 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, Michigan | |
| Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Study Coordinator 313-576-8496 | |
| United States, New Jersey | |
| Summit Medical Group PA | Recruiting |
| Florham Park, New Jersey, United States, 07932 | |
| Contact: Study Coordinator 973-436-1755 | |
| United States, New York | |
| White Plains Hospital | Recruiting |
| New York, New York, United States, 10601 | |
| Contact: Study Coordinator 914-849-7591 | |
| Mayo Clinic Rochester | Recruiting |
| Rochester, New York, United States, 55905 | |
| Contact: Study Coordinator 507-284-2030 | |
| 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, Texas | |
| Baylor University - Charles A. Sammons Cancer Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Study Coordinator 214-820-6168 | |
| United States, Washington | |
| Virginia Mason Medical Center | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Study Coordinator 206-287-5671 | |
| United States, West Virginia | |
| West Virginia University Hospitals, Inc | Recruiting |
| Morgantown, West Virginia, United States, 26506 | |
| Contact: Study Coordinator 304-293-2633 | |
| Belgium | |
| UZ Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Study Coordinator +3216341940 | |
| Finland | |
| Docrates Cancer Center | Recruiting |
| Helsinki, Finland, 00180 | |
| Contact: Study Coordinator +358505001856 | |
| Helsinki University Hospital | Recruiting |
| Helsinki, Finland, 00290 | |
| Contact: Study Coordinator +358505130234 | |
| Italy | |
| Azienda Ospedaliero Universitaria Ospedali Ruiniti | Recruiting |
| Ancona, Italy, 60126 | |
| Contact: Study Coordinator +390715965093 | |
| IRCCS Azienda Ospedaliera Universitaria San Martino | Recruiting |
| Genova, Italy, 16132 | |
| Contact: Study Coordinator +390105553977 | |
| Fondazione IRCCS Istituto Nazionale Dei Tumori | Recruiting |
| Milano, Italy, 20133 | |
| Contact: Study Coordinator +390223903835 | |
| Istituto Europeo Di Oncologia | Recruiting |
| Milano, Italy, 20141 | |
| Contact: Study Coordinator +390294372680 | |
| A.O.U Di Modena - Polclinico | Recruiting |
| Modena, Italy, 41124 | |
| Contact: Study Coordinator +393929175678 | |
| Universitaria Degli Studi Della Campania "Luigi Vanvitelli" U.O.C. Oncologia Medica | Recruiting |
| Napoli, Italy, 80138 | |
| Contact: Study Coordinator +390815666688 | |
| Policlinico Universitario Gemelli | Recruiting |
| Rome, Italy, 00168 | |
| Contact: Study Coordinator +393498756270 | |
| Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte | Recruiting |
| Siena, Italy, 53100 | |
| Contact: Study Coordinator +39577586335 | |
| Azienda Ospedaliera di Verona-Policlinico G.B. Rossi | Recruiting |
| Verona, Italy, 37134 | |
| Contact: Study Coordinator +39458126564 | |
| Japan | |
| Saitama Cancer Center | Recruiting |
| Saitama, Kita Adachi-Gun, Japan, 362-0806 | |
| Contact: Study Coordinator +81355755862 | |
| Chiba Cancer Center | Recruiting |
| Chiba, Japan, 260-8717 | |
| Contact: Study Coordinator +81342183500 | |
| National Hospital Organization Kyushu Cancer Center | Recruiting |
| Fukuoka-Shi, Japan, 811-1395 | |
| Contact: Study Coordinator +81925413231 | |
| Hokkaido University Hospital | Recruiting |
| Hokkaido, Japan, 060-8648 | |
| Contact: Study Coordinator +81117067600 | |
| Kobe University Hospital | Recruiting |
| Kobe, Japan, 650-0017 | |
| Contact: Study Coordinator +81783825111 | |
| Cancer Institute Hospital of JFCR | Recruiting |
| Koto-Ku, Japan, 135-8550 | |
| Contact: Study Coordinator +81363164620 | |
| NHO Shikoku Cancer Center | Recruiting |
| Matsuyama, Japan, 791-0280 | |
| Contact: Study Coordinator +81899991196 | |
| Osaka International Cancer Institute | Recruiting |
| Osaka-Shi, Japan, 541-8567 | |
| Contact: Study Coordinator +81662026677 | |
| Keio University Hospital | Recruiting |
| Shinanomachi, Japan, 160-8582 | |
| Contact: Study Coordinator +81353633899 | |
| Toyama University Hospital | Recruiting |
| Toyama, Japan, 930-0194 | |
| Contact: Study Coordinator +81776245900 | |
| Yamaguchi University Hospital | Recruiting |
| Ube, Japan, 755-8505 | |
| Contact: Study Coordinator +81825061631 | |
| Yokohama City University Medical Center | Recruiting |
| Yokohama, Japan, 232-0024 | |
| Contact: Study Coordinator +81452615656 | |
| Netherlands | |
| UMC Utrecht | Recruiting |
| Utrecht, Netherlands, 3584 CX | |
| Contact: Study Coordinator +31887556263 | |
| Spain | |
| Hospital de La Santa Creu I Sant Pau | Recruiting |
| Barcelona, Spain, 08026 | |
| Contact: Study Coordinator +34935565585 | |
| Hospital General Vall d'Hebron | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: Study Coordinator +34913368263 | |
| Hospital Clinic De Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Study Coordinator +34932275400 ext 3303 | |
| Hospital Materno Teresa Herrera | Recruiting |
| La Coruña, Spain, 15006 | |
| Contact: Study Coordinator +34981178000 ext 292872 | |
| Hospital General Universitario Gregorio Maranon | Recruiting |
| Madrid, Spain, 28007 | |
| Contact: Study Coordinator +34914269629 | |
| Hospital Universitario Ramon Y Cajal | Recruiting |
| Madrid, Spain, 28034 | |
| Contact: Study Coordinator +34913368263 | |
| Hospital Universitario HM Sanchinarro | Recruiting |
| Madrid, Spain, 28050 | |
| Contact: Study Coordinator +34917567800 | |
| Hospital Universitari Parc Tauli | Recruiting |
| Sabadell, Spain, 08208 | |
| Contact: Study Coordinator +34937240084 | |
| Sweden | |
| Karolinska University Hospital | Recruiting |
| Stockholm, Sweden, 14141 | |
| Contact: Study Coordinator +46851773484 | |
| United Kingdom | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, United Kingdom, CB2 0QQ | |
| Contact: Study Coordinator +441223348076 | |
| The Royal Marsden NHS Foundation Trust | Recruiting |
| London, United Kingdom, SW3 6JJ | |
| Contact: Study Coordinator +442086426011 | |
| Imperial College Healthcare NHS Trust - Hammersmith Hospital | Recruiting |
| London, United Kingdom, W12 0HS | |
| Contact: Study Coordinator +442033131000 | |
| The Christie NHS Foundation Trust | Recruiting |
| Manchester, United Kingdom, M20 4BV | |
| Contact: Study Coordinator +441614468106 | |
| The Royal Marsden NHS Foundation Trust | Recruiting |
| Sutton, United Kingdom, SM2 5PT | |
| Contact: Study Coordinator +442086426011 | |
Sponsors and Collaborators
Incyte Corporation
Investigators
| Study Director: | Luis Féliz, MD | Incyte Corporation |
| 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: | August 9, 2019 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Incyte Corporation:
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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 Gemcitabine Cisplatin 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 |