This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).
This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398, administered on a continuous once and/or twice daily schedule.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Guangzhou, China
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Incidence rate and category of dose limiting toxicities (DLTs)
Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
Time frame: First cycle of 28 days
Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)
To characterize the safety and tolerability of oral BGJ398
Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
Changes in hematology and chemistry values
hematology and chemistry values
Time frame: From baseline to 28 days after treatment discontinuation
Assessments of physical examinations, vital signs and electrocardiograms (ECGs)
Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Time vs. concentration profiles
To determine the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax, T1/2, etc) of oral BGJ398 including known pharmacologically active metabolites
Time frame: 1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks
Preliminary anti-tumor activity
Assessed based on RECIST version 1.1
Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Best overall response (BOR)
Assessed by investigator per RECIST version 1.1. BOR is the best response recorded until disease progression.
Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
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National Cancer Center Hospital East (NCEE)
Kashiwa, Chiba, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Sayama, Osaka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Overall response rate (ORR)
Assessed by investigator per RECIST version 1.1. ORR is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR).
Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Progression-free survival (PFS)
PFS is defined as the times from the date of first dose of BGJ398 to the date of the first documented disease progression, date of death due to any cause or until a new anticancer therapy is initiated, whichever occurs first.
Time frame: From date of end of treatment until the date of progression, or date of death, or starting date of a new anticancer therapy, assessed up to 100 months.
Duration of all Adverse Events (AEs)
To characterize the safety and tolerability of oral BGJ398
Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
Duration of Serious Advers Events (SAEs)
To characterize the safety and tolerability of oral BGJ398
Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
Severity of all Adverse Events (AEs)
To characterize the safety and tolerability of oral BGJ398
Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
Severity of all Serious Advers Events (SAEs)
To characterize the safety and tolerability of oral BGJ398
Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation