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 : July 23, 2019
|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: ~120 patients, 108 with FGFR2 gene fusions or translocations and 12 with other FGFR genetic alterations enrolled under the original protocol and amendment 1.
Cohort 2: ~20 patients with FGFR genetic alterations other than FGFR2 gene fusions or translocations.
Cohort 3: Up to ~20 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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 14, 2014|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||July 2022|
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
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||650-231-4088||clinicaltrials@QEDTx.com|
|Contact: QED Therapeutics||clinicaltrials@QEDTx.com|
Show 30 Study Locations
|Study Director:||QED Therapeutics||QED Therapeutics|