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JOURNAL ONKOLOGIE – STUDIE
FIGHT-302

A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

Rekrutierend

NCT-Nummer:
NCT03656536

Studienbeginn:
Juni 2019

Letztes Update:
10.04.2024

Wirkstoff:
Pemigatinib, Gemcitabine, Cisplatin

Indikation (Clinical Trials):
Cholangiocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Incyte Corporation

Collaborator:
-

Studienleiter

Peter Langmuir, MD
Study Director
Incyte Corporation

Kontakt

Incyte Corporation Call Center (ex-US)
Kontakt:
Phone: +800 00027423
E-Mail: globalmedinfo@incyte.com» Kontaktdaten anzeigen

Studienlocations
(3 von 218)

University Medical Center Rwth Aachen
52074 Aachen
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Charite - Campus Virchow-Klinikum
13353 Berlin
(Berlin)
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Charite Universitaetsmedizin Berlin - Campus Charite Mitte
13353 Berlin
(Berlin)
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Universitatsklinikum Bonn Aoer
53127 Bonn
(Nordrhein-Westfalen)
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Klinikum Bremen-Nord
28755 Bremen
(Bremen)
GermanyAbgeschlossen» Google-Maps
University Clinic Carl Gustav Carus Technical University Dresden
01307 Dresden
(Sachsen)
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Klinikum Der Johann Wolfgang Goethe University
60590 Frankfurt Am Main
(Hessen)
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University Medical Center Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Universitatsklinikum Hamburg Eppendorf
20246 Hamburg
(Hamburg)
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Asklepios Klinik Altona
22763 Hamburg
(Hamburg)
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Hannover Medical School
30625 Hannover
(Niedersachsen)
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Universitaetsklinikum Des Saarlandes
66421 Homburg / Saar
(Saarland)
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Universitatsklinikum Koln
50937 Koln
(Nordrhein-Westfalen)
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Universitatsklinikum Leipzig Aor
04103 Leipzig
(Sachsen)
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Klinikum Ludwigsburg
71640 Ludwigsburg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Otto-Von-Guericke-Universitat Magdeburg
39120 Magdeburg
(Sachsen-Anhalt)
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Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
55131 Mainz
(Rheinland-Pfalz)
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University Hospital Grosshadern Munich
81377 Munich
(Bayern)
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Klinikum Nuernberg
90419 Nuernberg
(Bayern)
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Universitaetsklinikum in Tubingen
72076 Tubingen
(Baden-Württemberg)
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University Hospital Tuebingen
72076 Tubingen
(Baden-Württemberg)
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Universitatkinikums Ulm
89081 ULM
(Baden-Württemberg)
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Georgetown University-Lombardi Comprehensive Cancer Center
20007 Washington
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Winship Cancer Institute of Emory University
30322 Atlanta
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University of Chicago Medical Center
60637-1447 Chicago
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Parkview Research Center
46845 Fort Wayne
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University of Iowa Hospital and Clinics
52242 Iowa City
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The University of Kansas Cancer Center
66205 Westwood
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Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
70121 New Orleans
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Johns Hopkins Oncology Center
21287 Baltimore
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Beth Israel Deaconess Medical Center
02215 Boston
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Comprehensive Cancer Centers of Nevada-Twain
89169 Las Vegas
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Icahn School of Medicine At Mount Sinai
10029 New York
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Memorial Sloan Kettering Cancer Center
10065 New York
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White Plains Hospital
10601 White Plains
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University Hospitals Cleveland Medical Center
44106 Cleveland
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Cleveland Clinic Foundation
44195 Cleveland
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Oregon Health & Science University
97239 Portland
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Greenville Hospital System University Medical Center Institute For Translational Oncology Research
29605 Greenville
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Baylor Scott and White Research Institute
75246 Dallas
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Houston Methodist Research Institute
77030 Houston
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Riverside Regional Medical Center
23601 Newport News
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Virginia Commonwealth University
23229 Richmond
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West Virginia University Cancer Institute
26506 Morgantown
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Aurora Research Institute
53226 Wauwatosa
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Landeskrankenhaus Universitatsklinikum Graz
08036 Graz
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Innsbruck University Hospital
A-6020 Innsbruck
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Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
04010 Linz
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05020 Salzburg
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01090 Vienna
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01090 Bruxelles
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08500 Kortrijk
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03000 Leuven
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Chu Ucl Namur University Hospital Mont-Godinne
05530 Yvoir
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MG5 2M9 Toronto
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Peking Union Medical College Hospital
100032 Beijing
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610041 Chengdu
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510000 Guangdong
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510000 Guangzhou
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310000 Hangzhou
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The Second Affiliated Hospital of Zhejiang University School of Medicine
310009 Hangzhou
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Heilongjiang Province Cancer Hospital
150081 Harbin
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University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
230001 Hefei
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Kunming 1St People'S Hospital
650032 Kunming
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266071 Shandong
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200032 Shanghai
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200092 Shanghai
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Tianjin Medical University Cancer Institute Hospital
300060 Tianjin
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Tongji Hospital Huazhong University of Science and Technology
430030 Wuhan
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Northern Jiangsu Peoples Hospital
225001 Yangzhou
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Helsinki University Central Hospital
00290 Helsinki
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Tampere University Hospital
33521 Tampere
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Institut Sainte Catherine
84918 Avignon Cedex 9
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Chu Besancon Hospital Jean Minjoz
25030 Besançon
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Chu de Limoges - Hospital Dupuytren
87042 Limoges Cedex
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Hopital Prive Jean Mermoz
69373 Lyon Cedex 08
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Chu Hopital de La Timone
13385 Marseille Cedex 5
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Centre Hospitalier Universitaire de Nantes
44000 Nantes
FranceNoch nicht rekrutierend» Google-Maps
Centre Antoine Laccassagne
06189 Nice Cedex 02
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Hospital Universitaire Pitie-Salpetriere
75013 Paris Cedex 13
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Hopital Europeen Georges Pompidou (Hegp)
75015 Paris Cedex 15
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Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
336600 Pessac Cedex
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Hospital de La Miletrie
86021 Poitiers Cedex
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Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
76031 Rouen Cedex
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University Hospital of Saint Etienne
42055 Saint Etienne
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Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
44800 Saint Herblain
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Chu Toulouse Hopital Rangueil
31059 Toulouse Cedex 9
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Chu Vandoeuvre-Les-Nancy Hopital Brabois
54511 Vandoeuvre Les Nancy
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Institut Gustave Roussy
94805 Villejuif Cedex
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St. Vincent'S University Hospital
D04 Y8V0 Dublin 4
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Soroka University Medical Center
84001 Beer-sheva
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Hadassah University Hospital
9112001 Jerusalem
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Rabin Medical Center - Beilinson Hospital
4941492 Petach Tikva
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Tel Aviv Sourasky Medical Center
64239 Tel Aviv
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Azienda Ospedaliero Universitaria Delle Marche
60126 Ancona
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Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
40138 Bologna
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Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
10060 Candiolo
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Presidio Ospedaliero Garibaldi Nesima
95100 Catania
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Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
20132 Milan
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Istituto Nazionale Tumori Irccs Fondazione Pascale
80131 Napoli
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Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
10043 Orbassano
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Iov - Istituto Oncologico Veneto Irccs
35128 Padova
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Azienda Ospedaliera Universitaria Pisana
56126 Pisa
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Istituto Nazionale Tumori Regina Elena Irccs
00144 Roma
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Universita Campus Bio Medico Di Roma
00128 Rome
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Azienda Ospedaliera San Camillo Forlanini
00152 Rome
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Irccs Istituto Clinico Humanitas
20089 Rozzano
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Kyushu University Hospital
812-8582 Fukuoka-shi
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Hiroshima University Hospital
734-8551 Hiroshima-shi
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Hyogo College of Medicine Hospital
663-8501 Hyogo
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Teikyo University Hospital
173-8606 Itabashi-ku
JapanNoch nicht rekrutierend» Google-Maps
Kyoto University Hospital
606-8507 Kyoto-shi
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Nho Shikoku Cancer Center
791-0280 Matsuyama-shi
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Kyorin University Hospital
181-8611 Mitaka-shi
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Aichi Cancer Center Hospital
464-8681 Nagoya-shi
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Niigata Cancer Center Hospital
951-8566 Niigata
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Kindai University Hospital
589-8511 Osakasayama City
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Hokkaido University Hospital
060-8648 Sapporo-shi
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Tohoku University Hospital
980-8574 Sendai-shi
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Jichi Medical University Hospital
329-0498 Shimotsuke-shi
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Osaka University Hospital
565-0871 Suita-shi
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Toyama University Hospital
930-0194 Toyama-shi
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Wakayama Medical University Hospital
641-8509 Wakayama
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Yokohama City University Medical Center
232-0024 Yokohama-shi
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Kanagawa Cancer Center
241-8515 Yokohama-shi
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Amsterdam University Medical Centre
1100 DD Amsterdam
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Hospital de La Santa Creu I Sant Pau
08026 Barcelona
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Hospital Clinic Barcelona Main
08036 Barcelona
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14004 Cordoba
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28034 Madrid
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28050 Madrid
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31008 Pamplona
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08208 Sabadell
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39008 Santander
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46014 Valencia
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413 46 Göteborg
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03010 Bern
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08091 Zuerich
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AB25 2ZN Aberdeen
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CB2 0QQ Cambridge
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WC1E 6BT London
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Kent Oncology Centre - Maidstone Hospital
ME16 9QQ Maidstone
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Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Male and female participants at least 18 years of age at the time of signing the

informed consent form (ICF).

- 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, or enrolled

as of Amendment 6 (or Amendment 5-JP2) and the participant received 1 cycle of

gemcitabine plus cisplatin [the start of study drug {Cycle 1 Day 1} must be at least

14 days and ≤ 4 weeks {28 days} from the last dose of gemcitabine plus cisplatin]).

- 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).

- Significant gastrointestinal disorders 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 or

antifungal or antiviral treatment within 2 weeks prior to enrollment (participants

with asymptomatic chronic infections on prophylactic treatment are allowed). Note:

HIV-positive participants are allowed if all of the following criteria are met: CD4+

count ≥ 300/µL, undetectable viral load, receiving antiretroviral therapy that does

not interact with study drug, and no HIV/AIDS-associated opportunistic infection in

the last 12 months.

- 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.

Studien-Rationale

Primary outcome:

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:

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)

Studien-Arme

  • Experimental: Pemigatinib
  • 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 to cross over and receive pemigatinib.

Geprüfte Regime

  • Pemigatinib (INCB054828):
    Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).
  • 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.
  • 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.

Quelle: ClinicalTrials.gov


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"A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma"

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