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

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ClinicalTrials.gov Identifier: NCT02150967
Recruitment Status : Recruiting
First Posted : May 30, 2014
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
QED Therapeutics, Inc.

Study Description
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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 consists of 28 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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


Outcome Measures
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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


Eligibility Criteria
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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.

Contacts and Locations
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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


Contacts
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Contact: QED Therapeutics 877-280-5655 clinicaltrials@QEDTx.com
Contact: QED Therapeutics clinicaltrials@QEDTx.com

Locations
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United States, Arizona
QED Investigative Site Completed
Phoenix, Arizona, United States, 85054
United States, California
QED Investigative Site Recruiting
Los Angeles, California, United States, 90033
Contact: Luevano Janelle    323-865-3160    janelle.luevano@med.usc.edu   
Principal Investigator: Anthony El-Khoueiry         
QED Investigative Site Recruiting
Los Angeles, California, United States, 90095
Contact: Nicole Williams    310-829-5471    ssadeghi@mednet.ucla.edu   
Principal Investigator: Saeed Sadeghi, MD         
QED Investigative Site Recruiting
San Francisco, California, United States, 94158
Contact       clinicaltrials@QEDTx.com   
United States, Massachusetts
QED Investigative Site Recruiting
Boston, Massachusetts, United States, 02114
Contact: Patricia Lynch, RN    617-724-4000    lynch.patricia2@mgh.harvard.edu   
United States, Michigan
QED Investigative Site Recruiting
Detroit, Michigan, United States, 48201
Contact: Taylor Brewer    313-576-8526    brewert@karmanos.org   
Principal Investigator: Philip A. Philip, MD         
United States, New York
QED Investigative Site Recruiting
New York, New York, United States, 10016
Contact: Pamela Baga       pamela.baga@nyulangone.org   
Principal Investigator: Paul Oberstein, MD         
QED Investigative Site Completed
New York, New York, United States, 10029
QED Investigative Site Recruiting
New York, New York, United States, 10065
Contact       clinicaltrials@QEDTx.com   
United States, Ohio
QED Investigative Site Recruiting
Columbus, Ohio, United States, 43221
Contact: Hamida Uman    614-685-5842    sameek.roychowdhury@osumc.edu   
Principal Investigator: Sameek Roychowdhury         
United States, Texas
QED Investigative Site Recruiting
Houston, Texas, United States, 77030-4009
Contact: Shanequa Manuel    713-792-9545    smanual@mdanderson.org   
Principal Investigator: Milind Javle         
Belgium
QED Investigative Site Recruiting
Brussels, Belgium, 1200
Contact: Tuan Le    +32 2 769 9213    trong.le@uclouvain.be   
Principal Investigator: Ivan Borbath, MD         
QED Investigative Site Completed
Leuven, Belgium, 3000
Germany
QED Investigative Site Recruiting
Koeln, Nordrhein-Westfalen, Germany, 50937
Contact: Duygu Cay    49 221 478    dirk-thomas.waldschmidt@uk-koeln.de   
QED Investigative Site Recruiting
Heidelberg, Germany, 69120
Contact: Ulrike Lauterbach    +49 6221 56-7684      
QED Investigative Site Recruiting
Tuebingen, Germany
Contact: Ursula Koppenhoefer    +49 7071-298-4457    ursula.koppenhoefer@med.uni-tuebingen.de   
Italy
QED Investigative Site Terminated
Ancona, AN, Italy, 60126
QED Investigative Site Terminated
Milano, MI, Italy, 20132
QED Investigative Site Terminated
Roma, RM, Italy, 00168
Korea, Republic of
QED Investigative Site Completed
Seoul, Korea, Korea, Republic of, 03080
QED Investigative Site Completed
Seoul, Korea, Korea, Republic of, 06351
Russian Federation
QED Investigative Site Terminated
Moscow, Russian Federation, 125367
QED Investigative Site Terminated
Volzhsky, Russian Federation, 404133
Singapore
QED Investigative Site Recruiting
Singapore, Singapore, 119228
Contact: Lau Xinyi Xenier    65-67724670    wei_peng_yong@nuhs.edu.sg   
Contact    65-96540060      
Principal Investigator: Dr. Yong Wei Peng         
QED Investigative Site Completed
Singapore, Singapore, 169610
Spain
QED Investigative Site Recruiting
Barcelona, Spain, 8035
Contact: Jordi Perera    +93 489 43 75    jperera@vhio.net   
Principal Investigator: Teresa Macarulla, MD         
QED Investigative Site Recruiting
Barcelona, Spain, 8908
Contact: Cristina Iglesias    +34 932 607 063    ciglesias@iconcdogia.net   
Principal Investigator: Berta Laquente, MD         
QED Investigative Site Recruiting
Madrid, Spain, 28050
Contact    +91 756 7894      
Principal Investigator: Rafael Gallego, MD         
Taiwan
QED Investigative Site Completed
Taipei, Taiwan ROC, Taiwan, 10041
QED Investigative Site Completed
Zhunan, Taiwan, 35053
Thailand
QED Investigative Site Completed
Khon Kaen, THA, Thailand, 40002
QED Investigative Site Recruiting
Bangkok, Thailand, 10330
Contact: Wassana Somhanwong    +66254533    surbpong@yahoo.com   
Principal Investigator: Suebpong Tanasanvimon         
QED Investigative Site Recruiting
Bangkok, Thailand, 10400
Contact       clinicaltrials@QEDTx.com   
United Kingdom
QED Investigative Site Recruiting
Bebington, United Kingdom, CH63 4JY
Contact       clinicaltrials@QEDTx.com   
QED Investigative Site Recruiting
Birmingham, United Kingdom, B15 2TH
Contact: Kathy Guo    0121 371 2000    yuktingma@uhb.nhs.uk   
Principal Investigator: Yuk Ting Ma, MD         
QED Investigative Site Recruiting
Manchester, United Kingdom, M20 4BX
Contact       clinicaltrials@QEDTx.com   
QED Investigative Site Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Jeanette Martin    +44 115 969 1169 ext 58369      
Contact: ankit.rao@nhs.uk         
Principal Investigator: Ankit Rao, MD         
Sponsors and Collaborators
QED Therapeutics, Inc.
Investigators
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Study Director: QED Therapeutics QED Therapeutics
More Information
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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: December 2, 2020
Last Verified: December 2020
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