Overview

This trial is active, not recruiting.

Condition advanced cholangiocarcinoma
Treatment bgj398
Phase phase 2
Target FGFR
Sponsor Novartis Pharmaceuticals
Start date July 2014
End date July 2018
Trial size 59 participants
Trial identifier NCT02150967, 2013-005085-19, CBGJ398X2204

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 FGFR genetic alterations.

United States Texas
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
To estimate anti-tumor activity of BGJ398
bgj398
Capsule for oral use

Primary Outcomes

Measure
Overall response rate (ORR)
time frame: up to 24 months

Secondary Outcomes

Measure
Overall survival
time frame: up to 24 months
Progression free survival
time frame: up to 24 months
Best overall response
time frame: up to 24 months
Disease control rate
time frame: up to 24 months
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
Selected trough and 2-hr Plasma concentration profile
time frame: up to 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inlcusion 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 - 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 - AST/SGOT and ALT/SGPT > 2.5x ULN (AST and ALT > 5x 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.

Additional Information

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
Description Adult patients with histologically or cytologically confirmed advanced or metastatic cholangiocarcinoma with FGFR2 gene fusion/ translocation or other FGFR genetic alteration 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 information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Novartis.
Location data was received from the National Cancer Institute and was last updated in July 2016.