An open-label, randomized, actively controlled, multicenter phase III study to evaluate the efficacy and safety of Pemigatinib versus Gemcitabine plus chemotherapy with Cisplatin as first-line treatment in patients with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement (FIGHT-302)

Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States (ICTRP)

ID di studio ICTRP
NCT03656536 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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) (BASEC)

Titolo accademico
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) (ICTRP)

Titolo pubblico
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma (ICTRP)

Malattie studiate
Unresectable CholangiocarcinomaMetastatic Cholangiocarcinoma (ICTRP)

Intervento studiato
Drug: PemigatinibDrug: GemcitabineDrug: Cisplatin (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
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/L, 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. (ICTRP)

non disponibile

Endpoint primari e secondari
Progression-free survival (ICTRP)

Overall response rate;Overall survival;Duration of response;Disease control rate;Number of treatment-emergent adverse events;Quality of Life impact as assessed by the EQ-5D-3L questionnaire;Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire;Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Peter Langmuir, MD, Incyte Corporation (ICTRP)

ID secondari
2024-513513-12-00, 2018-002894-23, INCB 54828-302 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT03656536 (ICTRP)