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A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)

NCT03656536

Description:

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.

Related Conditions:
  • Cholangiocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: INCB 54828-302
  • NCT ID: NCT03656536

Conditions

  • Unresectable Cholangiocarcinoma
  • Metastatic Cholangiocarcinoma

Interventions

DrugSynonymsArms
PemigatinibINCB054828Pemigatinib
GemcitabineGemcitabine + Cisplatin
CisplatinGemcitabine + Cisplatin

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
PemigatinibExperimental
  • Pemigatinib
Gemcitabine + CisplatinActive ComparatorParticipants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive pemigatinib.
  • Gemcitabine
  • Cisplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Male and female participants at least 18 years of age at the time of signing the
             informed consent form (ICF); a legally minor participant from Japan needs written
             parental consent.

          -  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).

          -  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.

          -  Must not be 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).

          -  Gastrointestinal conditions/disorders that may raise gastric and/or small intestinal
             pH 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,
             antifungal or antiviral treatment within 2 weeks prior to enrollment.

          -  Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives
             (whichever is longer) before the first dose of study treatment.

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival
Time Frame:Up to approximately 12 months
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Overall response rate
Time Frame:Up to approximately 12 months
Safety Issue:
Description: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.
Measure:Overall survival
Time Frame:Up to approximately 12 months
Safety Issue:
Description:Defined as the time from date of randomization until death due to any cause.
Measure:Duration of response
Time Frame:Up to approximately 12 months
Safety Issue:
Description: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.
Measure:Disease control rate
Time Frame:Up to approximately 12 months
Safety Issue:
Description: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.
Measure:Number of treatment-emergent adverse events
Time Frame:Up to approximately 12 months
Safety Issue:
Description:Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measure:Quality of Life impact as assessed by the EQ-5D-3L questionnaire
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire
Time Frame:Up to 12 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Cholangiocarcinoma
  • fibroblast growth factor receptor inhibitor
  • FGFR
  • FGFR rearrangement

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