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

Arm | Intervention/treatment |
---|---|
Experimental: BGJ398 (infigratinib)
To estimate anti-tumor activity of BGJ398
|
Drug: BGJ398 (infigratinib)
Capsule for oral use |
- 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.
- 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 will be summarized by the proportion of patients having a best overall response of PR, CR, stable disease (SD) or PD.
- 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).
- 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 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

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

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
Contact: QED Therapeutics | 877-280-5655 | clinicaltrials@QEDTx.com | |
Contact: QED Therapeutics | clinicaltrials@QEDTx.com |
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 |
Study Director: | QED Therapeutics | QED Therapeutics |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
cholangiocarcinoma, FGFR2 gene fusion, FGFR genetic alteration |
Cholangiocarcinoma Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |