This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02150967
First received: May 12, 2014
Last updated: May 25, 2017
Last verified: May 2017
  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 FGFR genetic alterations.

Condition Intervention Phase
Advanced Cholangiocarcinoma Drug: BGJ398 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome 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 Outcome 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 is the best response recorded from the start of the treatment until disease progression.

  • 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 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 Plasma concentration profile [ Time Frame: up to 12 months ]
    To determine selected trough and 2-hr plasma concentrations of BGJ398


Estimated Enrollment: 120
Actual Study Start Date: July 14, 2014
Estimated Study Completion Date: June 29, 2020
Estimated Primary Completion Date: June 29, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGJ398
To estimate anti-tumor activity of BGJ398
Drug: BGJ398
Capsule for oral use

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02150967

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com

  Show 30 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02150967     History of Changes
Other Study ID Numbers: CBGJ398X2204
2013-005085-19 ( EudraCT Number )
Study First Received: May 12, 2014
Last Updated: May 25, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
cholangiocarcinoma,
FGFR2 gene fusion,
FGFR genetic alteration

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 23, 2017