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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02150967|
Recruitment Status : Recruiting
First Posted : May 30, 2014
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cholangiocarcinoma||Drug: BGJ398||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 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 :||October 18, 2019|
|Estimated Study Completion Date :||October 18, 2019|
To estimate anti-tumor activity of BGJ398
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 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
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: Novartis Pharmaceuticalsemail@example.com|
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
Show 30 Study Locations
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|