Have you or your loved ones been diagnosed with metastatic cholangiocarcinoma?

You may be eligible to participate in a metastatic cholangiocarcinoma clinical trial.

Have you or your loved ones been diagnosed with metastatic cholangiocarcinoma? You may be eligible to participate in a metastatic cholangiocarcinoma clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Metastatic Cholangiocarcinoma Clinical Trial

NCT03656536 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with metastatic cholangiocarcinoma?

You may be eligible to participate in a metastatic cholangiocarcinoma clinical trial.

Have you or your loved ones been diagnosed with metastatic cholangiocarcinoma? You may be eligible to participate in a metastatic cholangiocarcinoma clinical trial.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 434 Participants

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.

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Details for the study

Brief Title

A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

Official Title

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)

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus <br /> gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with <br /> unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

Treatments and/or Procedures

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.

Pemigatinib

Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Progression-free survival

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.

Up to approximately 12 months

Secondary

Disease control rate

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.

Up to approximately 12 months

Secondary

Duration of response

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.

Up to approximately 12 months

Secondary

Overall survival

Defined as the time from date of randomization until death due to any cause.

Up to approximately 12 months

Secondary

Overall response rate

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.

Up to approximately 12 months

Secondary

Number of treatment-emergent adverse events

Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

Up to approximately 12 months

Study Criteria

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/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.