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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2022

Detailed Description

Adult patients with histologically or cytologically confirmed advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or translocations or other 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. Up to approximately 160 adult patients over age 18, both male and female will be enrolled. Three cohorts of patients comprise the study population:

Cohort 1: patients with FGFR2 gene fusions or translocations and other FGFR genetic alterations enrolled under the original protocol and amendment 1.

Cohort 2: patients with FGFR genetic alterations other than FGFR2 gene fusions or translocations.

Cohort 3: patients with FGFR2 gene fusions or translocations who have received a prior FGFR inhibitor.

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.

Interventions

  • Drug: BGJ398 (infigratinib)
    • Capsule for oral use

Arms, Groups and Cohorts

  • Experimental: BGJ398 (infigratinib)
    • To estimate anti-tumor activity of BGJ398

Clinical Trial Outcome Measures

Primary Measures

  • Overall response rate (ORR)
    • Time Frame: up to 24 months
    • 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 Measures

  • Overall survival
    • Time Frame: up to 24 months
    • Overall Survival (OS) is defined as the time from the date of start of treatment to the date of death due to any cause.
  • Progression free survival
    • Time Frame: up to 24 months
    • 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.
  • Best overall response
    • Time Frame: up to 24 months
    • The best overall response will be summarized by the proportion of patients having a best overall response of PR, CR, stable disease (SD) or PD.
  • Disease control rate
    • Time Frame: up to 24 months
    • Disease control rate (DCR) is the proportion of patients with a best overall response of CR or PR or stable disease (SD).
  • 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
    • To characterize the safety and tolerability of single agent BGJ398 by the type, frequency and severity of AEs & SAEs.
  • Selected trough and 2-hr or 4-hr Plasma concentration profile
    • Time Frame: up to 12 months
    • To determine selected trough and 2-hr or 4-hr plasma concentrations of BGJ398

Participating in This Clinical Trial

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 inhibitor (all cohorts), BGJ398/infigratinib (all cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only).
  • 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • QED Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • QED Therapeutics, Study Director, QED Therapeutics
  • Overall Contact(s)
    • QED Therapeutics, 877-280-5655, clinicaltrials@QEDTx.com

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