Summary

for people ages 18 years and up (full criteria)
at UCLA UCSF
study started
estimated completion
Saeed Sadeghi(ucla)

Description

Summary

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.

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

Details

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.

Keywords

Advanced Cholangiocarcinoma FGFR2 Gene Mutation cholangiocarcinoma, FGFR2 gene fusion, FGFR genetic alteration Cholangiocarcinoma BGJ398 (infigratinib)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • QED Investigative Site accepting new patients
    Los Angeles California 90095 United States
  • QED Investigative Site accepting new patients
    San Francisco California 94143 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
QED Therapeutics, Inc.
ID
NCT02150967
Phase
Phase 2
Study Type
Interventional
Last Updated