Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Incyte Corporation (Voir sur ClinicalTrials)
juin 2019
juillet 2028
17 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | David MALKA | 17/01/2024 16:38:38 | Contact (sur clinicalTrials) | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Beaujon | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Laccassagne - 06189 - Nice Cedex 02 - France | Contact (sur clinicalTrials) | ||||
| Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau - 44800 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque - 336600 - Pessac Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nantes - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Chu Besancon Hospital Jean Minjoz - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| Chu de Limoges - Hospital Dupuytren - 87042 - Limoges Cedex - France | Contact (sur clinicalTrials) | ||||
| Chu Hopital de La Timone - 13385 - Marseille Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Chu Toulouse Hopital Rangueil - 31059 - Toulouse Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Chu Vandoeuvre-Les-Nancy Hopital Brabois - 54511 - Vandoeuvre Les Nancy - France | Contact (sur clinicalTrials) | ||||
| Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume - 76031 - Rouen Cedex - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive Jean Mermoz - 69373 - Lyon Cedex 08 - France | Contact (sur clinicalTrials) | ||||
| Hospital de La Miletrie - 86021 - Poitiers Cedex - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux Cedex - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - 84918 - Avignon Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| University Hospital of Saint Etienne - 42055 - Saint Etienne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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.