Clinical trial NCT02924376: Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
Official title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy - (FIGHT-202)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangiocarcinoma
Keywords: Cholangiocarcinoma
fibroblast growth factor (FGF)
fibroblast growth factor receptor (FGFR)
FGF/FGFR alterations
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed cholangiocarcinoma.
* Radiographically measurable or evaluable disease per RECIST v1.1.
* Tumor assessment for FGF/FGFR gene alteration status.
* Documented disease progression after at least 1 line of prior systemic therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Life expectancy ≥ 12 weeks.

Exclusion Criteria:

* Prior receipt of a selective FGFR inhibitor.
* History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
* Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
* Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.

Primary outcomes:
measure: Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions
timeFrame: up to 1527 days
Secondary outcomes:
measure: ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
timeFrame: up to 424 days
measure: ORR in All Participants With FGF/FGFR Alterations
timeFrame: up to 1527 days
measure: ORR in Participants Negative for FGF/FGFR Alterations
timeFrame: up to 143 days
measure: Progression-free Survival (PFS)
timeFrame: up to 50.17 months
measure: Duration of Response (DOR)
timeFrame: up to 47.11 months
measure: Disease Control Rate (DCR)
timeFrame: up to 1527 days
measure: Overall Survival
timeFrame: up to 51.32 months
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to 1584 days
measure: First-order Absorption Rate Constant (ka) of Pemigatinib
timeFrame: Predose; 1-2 hours post-dose; 4-12 hours post-dose
measure: CL/F of Pemigatinib
timeFrame: Predose; 1-2 hours post-dose; 4-12 hours post-dose
measure: Vc/F of Pemigatinib
timeFrame: Predose; 1-2 hours post-dose; 4-12 hours post-dose
measure: Vp/F of Pemigatinib
timeFrame: Predose; 1-2 hours post-dose; 4-12 hours post-dose
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Orange
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Sioux City
country: United States
state: Iowa
city: Westwood
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Woodbury
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Morristown
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Goldsboro
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sioux Falls
country: United States
state: South Dakota
city: Arlington
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Grapevine
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Fairfax
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Montpellier
country: France
state: Herault
city: Villejuif
country: France
state: Herault
city: Avignon
country: France
city: Clichy
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Dresden
country: Germany
city: Hannover
country: Germany
city: Homburg
country: Germany
city: Leipzig
country: Germany
city: Mainz
country: Germany
city: Tuebingen
country: Germany
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Tel Aviv
country: Israel
city: Bari
country: Italy
state: Castellana Grotte
city: San Giovanni Rotondo
country: Italy
state: Foggia
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Candiolo
country: Italy
city: Catania
country: Italy
city: Faenza
country: Italy
city: Lecce
country: Italy
city: Meldola
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Rimini
country: Italy
city: Siena
country: Italy
city: Verona
country: Italy
city: Nagoya-shi
country: Japan
state: Aichi-Ken
city: Chiba-shi
country: Japan
state: Chiba-Ken
city: Fukuoka-shi
country: Japan
state: Fukuoka-Ken
city: Yokohama-shi
country: Japan
state: Kanagawa-Ken
city: Kyoto-shi
country: Japan
state: Kyoto-Fu
city: Osaka-shi
country: Japan
state: Osaka-Fu
city: Osakasayama-shi
country: Japan
state: Osaka-Fu
city: Kitaadachi
country: Japan
state: Saitama-Ken
city: Sunto
country: Japan
state: Shizuoka-Ken
city: Koto-ku
country: Japan
state: Tokyo-To
city: Shinjuku-ku
country: Japan
state: Tokyo-To
city: Goyang-si
country: Korea, Republic of
city: Seongnam-si
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Pamplona
country: Spain
state: Navarra
city: Barcelona
country: Spain
city: Girona
country: Spain
city: Madrid
country: Spain
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Chiang Mai
country: Thailand
state: Muang
city: Khon Kaen
country: Thailand
state: Muang
city: Udon Thani
country: Thailand
state: Muang
city: Bangkok
country: Thailand
state: Patumwan
city: Bangkoknoi
country: Thailand
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: Bournemouth
country: United Kingdom
state: Dorset
city: Aberdeen
country: United Kingdom
state: Grampian Region
city: London
country: United Kingdom
state: Greater London
city: Cardiff
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Manchester
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Wirral
country: United Kingdom
Study officials:
affiliation: Incyte Corporation
name: Luis Féliz Vinas, MD
role: STUDY_DIRECTOR
References:
citation: Bibeau K, Feliz L, Lihou CF, Ren H, Abou-Alfa GK. Progression-Free Survival in Patients With Cholangiocarcinoma With or Without FGF/FGFR Alterations: A FIGHT-202 Post Hoc Analysis of Prior Systemic Therapy Response. JCO Precis Oncol. 2022 Apr;6:e2100414. doi: 10.1200/PO.21.00414.
citation: Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R, Paulson AS, Borad MJ, Gallinson D, Murphy AG, Oh DY, Dotan E, Catenacci DV, Van Cutsem E, Ji T, Lihou CF, Zhen H, Feliz L, Vogel A. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020 May;21(5):671-684. doi: 10.1016/S1470-2045(20)30109-1. Epub 2020 Mar 20.