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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03656536

Studienbeginn:
Juni 2019

Letztes Update:
30.10.2020

Wirkstoff:
pemigatinib, Gemcitabine, Cisplatin

Indikation (Clinical Trials):
Cholangiocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Incyte Corporation

Collaborator:
-

Studienleiter

Luis Féliz, 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 189)

University Medical Center Rwth Aachen
52074 Aachen
GermanyRekrutierend» Google-Maps
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Charite - Campus Virchow-Klinikum
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Bonn Aoer
53127 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Technische Universit�T Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Klinikum Der Johann Wolfgang Goethe University
60590 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
University Medical Center Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
University Medical Centre Hamburg-Eppendorf, Centre of Oncology
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Asklepios Klinik Altona
22763 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Hannover Medical School
30625 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
University Hospital Saarlandes
66424 Homburg/saar
(Saarland)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Koln
50937 Koln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Leipzig Aor
04103 Leipzig
(Sachsen)
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Klinikum Ludwigsburg
71640 Ludwigsburg
(Baden-Württemberg)
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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 Tubingen
72076 Tubingen
(Baden-Württemberg)
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Universitatsklinikum Ulm
89081 ULM
(Baden-Württemberg)
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UC Irvine Comprehensive Cancer Center
92868 Orange
United StatesAbgeschlossen» Google-Maps
Georgetown University Hospital
20007 Washington
United StatesAbgeschlossen» Google-Maps
University of Chicago Medical Center
60637 Chicago
United StatesAbgeschlossen» Google-Maps
Beth Israel Deaconess Medical Center
02215 Boston
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Comprehensive Cancer Center of Nevada
89169 Las Vegas
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University of Rochester, James P. Wilmot Cancer Center
14642 Rochester
United StatesNoch nicht rekrutierend» Google-Maps
University Hospitals Cleveland Medical Center
44106 Cleveland
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Houston Methodist Research Institute
77030 Houston
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West Virginia University Hospitals Inc
26506 Morgantown
United StatesAbgeschlossen» Google-Maps
Aurora Health Center
53226 Wauwatosa
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Lkh Graz - Universitatsklinik Fur Innere Medizin
08036 Graz
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Medical University Innsbruck
A-6020 Innsbruck
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Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
04010 Linz
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Paracelsus Medical University Salzburg
05020 Salzburg
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Az Groeninge - Campus Kennedylaan
08500 Kortrijk
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Universitaire Ziekenhuis Leuven - Gasthuisberg
03000 Leuven
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Chu Ucl Namur, University Hospital Mont-Godinne
05530 Yvoir
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Institut Sainte Catherine
84918 Avignon Cedex 9
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Besancon
25000 Besancon
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Chu Hopital de La Timone
13385 Marseille Cedex 5
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Hopital Universitaire Pitie-Salpetriere
75013 Paris
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Hopital Europeen Georges Pompidou (Hegp)
75015 Paris
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Centre Hospitalier Universitaire de Poitiers
86021 Poitiers
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Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume
76031 Rouen
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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 de Saint-Etienne
42270 Saint-priest-en-jarez
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Chu Toulouse Hopital Rangueil
31059 Toulouse Cedex 9
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Chu Nancy - Hopital Brabois
54511 Vandoeuvre Les Nancy
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Institute Gustave Roussy (Igr)
94800 Villejuif
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St. Vincent'S University Hospital
D04 Y8V0 Dublin 4
IrelandRekrutierend» Google-Maps
Hadassah Hebrew University Medical Center Ein Karem Hadassah
90000 Jerusalem
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Rabin Medical Center - Beilinson Hospital
4841492 Petach Tikva
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Azienda Ospedaliero-Universitaria Di Bologna - Policlinico S. Orsola-Malpighi
40138 Bologna
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Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
10060 Candiolo
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Na.O.U. Policlinico Vittorio Emanuele
95123 Catania
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Istituto Nazionale Tumori Fondazione Irccs G. Pascale
80131 Naples
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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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Universita Campus Bio-Medico Di Roma
00128 Roma
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Irrcs Instituto Clinico Humanitas
20089 Rozzano
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Hiroshima University Hospital
734-8551 Hiroshima-shi
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Hyogo College of Medicine Hospital
663-8501 Hyogo-ken
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Teikyo University Hospital
173-8606 Itabashi-ku
JapanNoch nicht rekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
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Tohoku University Hospital
980-8574 Sendai-shi
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Wakayama Medical University Hospital
641-8509 Wakayama
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Kanagawa Cancer Center
241-8515 Yokohama-shi
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Academic Medical Center
1105 AZ Amsterdam
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Hospital Clinic I Provincial
08036 Barcelona
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Hospital Universitario Reina Sofia
14004 Cordoba
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Hospital Universitario Marques de Valdecilla
39008 Santander
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Hospital General Universitario de Valencia
46014 Valencia
SpainRekrutierend» Google-Maps
Inselspital - Universitaetsspital Bern
03010 Bern
SwitzerlandRekrutierend» Google-Maps
Universtitatsspital Zurich
08091 Zurich
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Addenbrooke'S Hospital
CB2 0QQ Cambridge
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Velindre Cancer Centre
CF14 2TL Cardiff
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University Hospital Coventry and Warwickshire
CV2 2DX Coventry
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University College London Hospitals
WC1E 6BT London
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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); 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).

- 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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