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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02150967
Recruitment Status : Active, not recruiting
First Posted : May 30, 2014
Last Update Posted : November 9, 2021
Sponsor:
Collaborator:
Helsinn Healthcare SA
Information provided by (Responsible Party):
QED Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Cholangiocarcinoma FGFR2 Gene Mutation Drug: BGJ398 (infigratinib) Phase 2

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 consist of 28 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : July 23, 2014
Actual Primary Completion Date : March 1, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: BGJ398 (infigratinib)
To estimate anti-tumor activity of BGJ398
Drug: BGJ398 (infigratinib)
Capsule for oral use




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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



Information from the National Library of Medicine

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150967


Locations
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United States, Arizona
QED Investigative Site
Phoenix, Arizona, United States, 85054
United States, California
QED Investigative Site
Los Angeles, California, United States, 90033
QED Investigative Site
Los Angeles, California, United States, 90095
QED Investigative Site
San Francisco, California, United States, 94158
United States, Massachusetts
QED Investigative Site
Boston, Massachusetts, United States, 02114
United States, Michigan
QED Investigative Site
Detroit, Michigan, United States, 48201
United States, New York
QED Investigative Site
New York, New York, United States, 10016
QED Investigative Site
New York, New York, United States, 10029
QED Investigative Site
New York, New York, United States, 10065
United States, Ohio
QED Investigative Site
Columbus, Ohio, United States, 43221
United States, Texas
QED Investigative Site
Houston, Texas, United States, 77030-4009
Belgium
QED Investigative Site
Brussels, Belgium, 1200
QED Investigative Site
Leuven, Belgium, 3000
Germany
QED Investigative Site
Koeln, Nordrhein-Westfalen, Germany, 50937
QED Investigative Site
Heidelberg, Germany, 69120
QED Investigative Site
Tuebingen, Germany
Italy
QED Investigative Site
Ancona, AN, Italy, 60126
QED Investigative Site
Milano, MI, Italy, 20132
QED Investigative Site
Roma, RM, Italy, 00168
Korea, Republic of
QED Investigative Site
Seoul, Korea, Korea, Republic of, 03080
QED Investigative Site
Seoul, Korea, Korea, Republic of, 06351
Russian Federation
QED Investigative Site
Moscow, Russian Federation, 125367
QED Investigative Site
Volzhskiy, Russian Federation, 404133
Singapore
QED Investigative Site
Singapore, Singapore, 119228
QED Investigative Site
Singapore, Singapore, 169610
Spain
QED Investigative Site
Barcelona, Spain, 8035
QED Investigative Site
Barcelona, Spain, 8908
QED Investigative Site
Madrid, Spain, 28050
Taiwan
QED Investigative Site
Taipei, Taiwan ROC, Taiwan, 10041
QED Investigative Site
Zhunan, Taiwan, 35053
Thailand
QED Investigative Site
Khon Kaen, THA, Thailand, 40002
QED Investigative Site
Bangkok, Thailand, 10330
QED Investigative Site
Bangkok, Thailand, 10400
United Kingdom
QED Investigative Site
Bebington, United Kingdom, CH63 4JY
QED Investigative Site
Birmingham, United Kingdom, B15 2TH
QED Investigative Site
Manchester, United Kingdom, M20 4BX
QED Investigative Site
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
QED Therapeutics, Inc.
Helsinn Healthcare SA
Investigators
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Study Director: QED Therapeutics QED Therapeutics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: QED Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02150967    
Other Study ID Numbers: CBGJ398X2204
2013-005085-19 ( EudraCT Number )
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by QED Therapeutics, Inc.:
cholangiocarcinoma,
FGFR2 gene fusion,
FGFR genetic alteration
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Infigratinib
Antineoplastic Agents