Clinical Trials /

A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

NCT02150967

Description:

This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with Fibroblast Growth Factor receptor (FGFR) genetic alterations.

Related Conditions:
  • Cholangiocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
  • Official Title: A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: CBGJ398X2204
  • SECONDARY ID: 2013-005085-19
  • NCT ID: NCT02150967

Conditions

  • Advanced Cholangiocarcinoma
  • FGFR2 Gene Mutation

Interventions

DrugSynonymsArms
BGJ398 (infigratinib)BGJ398 (infigratinib)

Purpose

This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with Fibroblast Growth Factor receptor (FGFR) genetic alterations.

Detailed Description

      Adult patients with histologically or cytologically confirmed advanced or metastatic
      cholangiocarcinoma with FGFR genetic alterations who have evidence of radiologic progression
      following a cisplatin-and gemcitabine-containing regimen for advanced disease or a
      gemcitabine-containing regimen for those who are considered intolerant to cisplatin will be
      enrolled. Approximately 55 adult patients over age 18, both male and female will be enrolled.
      Of these 55 patients, 40 patients will have cholangiocarcinoma with identified FGFR2 gene
      fusions and up to 15 patients may have other FGFR genetic alterations. All patients will
      receive oral BGJ398, once daily, on a three weeks on (21 days), one week off (7 days)
      schedule. One treatment cycle will consists of 28 days.
    

Trial Arms

NameTypeDescriptionInterventions
BGJ398 (infigratinib)ExperimentalTo estimate anti-tumor activity of BGJ398
  • BGJ398 (infigratinib)

Eligibility Criteria

        Inclusion criteria:

        - Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the
        time of diagnosis.

        Patients with cancers of the gallbladder or ampulla of Vater are not eligible.

        - Patients must have received at least one prior regimen containing gemcitabine with or
        without cisplatin for advanced/ metastatic disease. Patient should have evidence of
        progressive disease following prior regimen, or if prior treatment discontinued due to
        toxicity must have continued evidence of measurable or evaluable disease.

        Exclusion criteria:

          -  Prior or current treatment with a MEK or selective FGFR inhibitor

          -  insufficient organ function

               -  Absolutely Neutrophil Count (ANC) < 1,000/mm3 [1.0 x 109/L]

               -  Platelets < 75,000/mm3 [75 x 109/L]

               -  Hemoglobin < 109.0 g/dL

               -  Total bilirubin > 1.5x ULN

               -  Aspartate aminotransferase/glutamic oxaloacetic transaminase/GOT (AST/SGOT) and
                  Alanine aminotransferase/glutamic pyruvic transaminase/GPT (ALT/SGPT) > 2.5x ULN
                  (AST and ALT) > 5x upper limit of normal (ULN) in the presence of liver
                  metastases)

               -  Serum creatinine > 1.5x ULN and a calculated or measured creatinine clearance <
                  45 mL/min

               -  Inorganic phosphorus outside of normal limits

               -  Total and ionized serum calcium outside of normal limits

        Other protocol-defined inclusion/exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:up to 24 months
Safety Issue:
Description:Overall response rate (ORR) is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), as per RECIST version 1.1.

Secondary Outcome Measures

Measure:Overall survival
Time Frame:up to 24 months
Safety Issue:
Description:Overall Survival (OS) is defined as the time from the date of start of treatment to the date of death due to any cause.
Measure:Progression free survival
Time Frame:up to 24 months
Safety Issue:
Description:Progression free survival (PFS) is defined as the date of the start of treatment to the date of the event defined as the first documented progression or death due to any cause.
Measure:Best overall response
Time Frame:up to 24 months
Safety Issue:
Description:The best overall response is the best response recorded from the start of the treatment until disease progression.
Measure:Disease control rate
Time Frame:up to 24 months
Safety Issue:
Description:Disease control rate (DCR) is the proportion of patients with a best overall response of CR or PR or stable disease (SD).
Measure:Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability
Time Frame:up to 24 months
Safety Issue:
Description:To characterize the safety and tolerability of single agent BGJ398 by the type, frequency and severity of AEs & SAEs.
Measure:Selected trough and 2-hr Plasma concentration profile
Time Frame:up to 12 months
Safety Issue:
Description:To determine selected trough and 2-hr plasma concentrations of BGJ398

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:QED Therapeutics, Inc.

Trial Keywords

  • cholangiocarcinoma,
  • FGFR2 gene fusion,
  • FGFR genetic alteration

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