Freitag, 26. Februar 2021
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JOURNAL ONKOLOGIE – STUDIE

Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

Rekrutierend

NCT-Nummer:
NCT03822117

Studienbeginn:
Mai 2019

Letztes Update:
30.10.2020

Wirkstoff:
pemigatinib

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

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 89)

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
Universitatsklinikum Koln
50937 Koln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
University Hospital Grosshadern Munich
81377 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
The University of Arizona Cancer Center
85724 Tucson
United StatesRekrutierend» Google-Maps
Stanford Cancer Center
94304 Palo Alto
United StatesRekrutierend» Google-Maps
Mayo Clinic Jacksonville
32224 Jacksonville
United StatesRekrutierend» Google-Maps
Illinois Cancer Specialists
60005 Arlington Heights
United StatesRekrutierend» Google-Maps
Edward H Kaplan & Associates
60076 Skokie
United StatesRekrutierend» Google-Maps
Indiana University Health - Arnett Cancer Care
47904 Lafayette
United StatesRekrutierend» Google-Maps
University of Kansas Cancer Center
66205 Westwood
United StatesRekrutierend» Google-Maps
Central Maine Medical Center
04240 Lewiston
United StatesRekrutierend» Google-Maps
Umass Memorial Medical Center, Inc.
01655 Worcester
United StatesRekrutierend» Google-Maps
Mayo Clinic Rochester
55905 Rochester
United StatesRekrutierend» Google-Maps
Dartmouth Hitchcock Medical Center
03756 Lebanon
United StatesRekrutierend» Google-Maps
Winthrop University Hospital
11501 Mineola
United StatesRekrutierend» Google-Maps
Wake Forest Baptist Medical Center
27157 Winston-Salem
United StatesRekrutierend» Google-Maps
Stephenson Cancer Center
73104 Oklahoma City
United StatesRekrutierend» Google-Maps
Cancer Institute of Greenville Health System
29605 Greenville
United StatesRekrutierend» Google-Maps
Joe Arrington Cancer Center
79410 Lubbock
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists, Pc
22031 Fairfax
United StatesRekrutierend» Google-Maps
Virginia Oncology Associates-Lake Wright
23502 Norfolk
United StatesRekrutierend» Google-Maps
Seattle Cancer Care Alliance
98109 Seattle
United StatesRekrutierend» Google-Maps
Multicare Institute For Research & Innovation
98405 Tacoma
United StatesAbgeschlossen» Google-Maps
West Virginia University Hospitals Inc
26506 Morgantown
United StatesRekrutierend» Google-Maps
University of Wisconsin Carbone Cancer Center
53792 Madison
United StatesRekrutierend» Google-Maps
The Finsen Centre, National Hospital
02100 Copenhagen
DenmarkRekrutierend» Google-Maps
Centre Georges Francois Leclerc
21079 Dijon Cedex
FranceRekrutierend» Google-Maps
Institut Claudius Regaud Oncopole Toulouse
31100 Toulouse
FranceRekrutierend» Google-Maps
Hadassah Hebrew University Medical Center Ein Karem Hadassah
90000 Jerusalem
IsraelRekrutierend» Google-Maps
Rabin Medical Center - Beilinson Hospital
4841492 Petach Tikva
IsraelRekrutierend» Google-Maps
Assaf Harofeh Medical Center
7030000 Zerifin
IsraelRekrutierend» Google-Maps
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola ? Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
10060 Candiolo
ItalyRekrutierend» Google-Maps
Fondazione Irccs Istituto Nazionale Dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps
Centro Ricerche Cliniche Di Verona (Crc)
37134 Verona
ItalyRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka
JapanRekrutierend» Google-Maps
Kanazawa University Hospital
920-8641 Ishikawa
JapanRekrutierend» Google-Maps
Tohoku University Hospital
980-8574 Sendai-shi
JapanRekrutierend» Google-Maps
Keio University Hospital
160-8582 Shinjuku-ku
JapanRekrutierend» Google-Maps
Kanagawa Cancer Center
241-8515 Yokohama-shi
JapanRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Inselspital - Universitaetsspital Bern
03010 Bern
SwitzerlandRekrutierend» Google-Maps
Zurich University Hospital
08091 Zurich
SwitzerlandRekrutierend» Google-Maps
University College London Hospitals (Uclh)
NW1 2PG London
United KingdomRekrutierend» Google-Maps
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
W12 0HS London
United KingdomRekrutierend» Google-Maps
The Christie Nhs Foundation Trust Uk
M20 4BV Manchester
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to evaluate the efficacy and safety of pemigatinib in

participants with previously treated locally advanced/metastatic or surgically unresectable

solid tumor malignancies harboring activating FGFR mutations or translocations.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically or cytologically confirmed solid tumor malignancy that is advanced or

metastatic or is surgically unresectable.

- Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain

tumors). Tumor lesions located in a previously irradiated area or in an area subjected

to other loco-regional therapy are considered measureable if progression has been

clearly demonstrated in the lesion.

- Documentation of an FGFR1-3 gene mutation or translocation.

- Objective progression after at least 1 prior therapy and no therapy available that is

likely to provide clinical benefit. Participants who are intolerant to or decline the

approved therapy are eligible only if they have no therapy available that is likely to

provide clinical benefit.

- Eastern Cooperative Oncology Group performance status 0 to 2.

- Baseline archival tumor specimen (if < 12 months from date of screening) or

willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a

tumor block or approximately 15 unstained slides from biopsy or resection of primary

tumor or metastasis.

- Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

- Prior receipt of a selective FGFR inhibitor in the past 6 months.

- Receipt of anticancer medications or investigational drugs for any indication or

reason within 28 days before first dose of pemigatinib.

- Cannot be a candidate for potentially curative surgery.

- Current evidence of clinically significant corneal or retinal disorder as confirmed by

ophthalmologic examination.

- Radiation therapy administered within 2 weeks of enrollment/first dose of study

treatment.

- Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases

that have progressed (eg, evidence of new or enlarging brain metastasis or new

neurological symptoms attributable to brain or CNS metastases).

- Known additional malignancy that is progressing or requires active treatment.

- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance

with ectopic calcification of soft tissues.

- Clinically significant or uncontrolled cardiac disease.

- Active chronic or current infectious disease requiring systemic antibiotic,

antifungal, or antiviral treatment within 2 weeks before enrollment (participants with

asymptomatic chronic infections on prophylactic treatment are allowed).

- Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

(defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no

cirrhosis and no elevated transaminases is allowed).

- Known HIV infection.

- Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14

days or five half-lives (whichever is longer) before the first dose of study

drug/treatment.

- Women who are pregnant or breastfeeding.

Studien-Rationale

Primary outcome:

1. Objective response rate (ORR) in Cohort A (Time Frame - Up to approximately 6 months):
Defined as the proportion of participants in Cohort A who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO) as determined by an independent radiological review committee.

2. ORR in Cohort B (Time Frame - Up to approximately 6 months):
Defined as the proportion of participants in Cohort B who achieve a CR or PR based on RECIST v1.1 or RANO as determined by an independent radiological review committee.

Secondary outcome:

1. Progression-free survival (PFS) (Time Frame - Up to approximately 6 months):
Defined as the time from first dose until progressive disease (according to RECIST v1.1 or RANO and assessed by an independent central review) or death (whichever is first) in Cohorts A and B, respectively.

2. Duration of response (DOR) (Time Frame - Up to approximately 6 months):
Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (according to RECIST v1.1 or RANO and assessed by an independent central review) or death (whichever is first) in Cohorts A and B, respectively.

3. Overall survival (OS) (Time Frame - Up to approximately 6 months):
Defined as the time from first dose of study drug to death of any cause in Cohorts A and B, respectively.

4. Number of treatment-emergent adverse events (Time Frame - Up to approximately 6 months):
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

5. Number of treatment-related adverse events. (Time Frame - Up to approximately 6 months):
Adverse events considered to be treatment-related by the investigator.

Geprüfte Regime

  • Pemigatinib (INCB054828):
    Pemigatinib administered orally once daily (QD).

Quelle: ClinicalTrials.gov


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