Tumor With Alterations of the FGF-R
Conditions
Keywords
Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R
Brief summary
This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).
Detailed description
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.
Interventions
DRUGBGJ398
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with advanced solid tumors with FGF-R alteration * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Adequate organ function
Exclusion criteria
* Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease * Pregnant or nursing (lactating) women Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate and category of dose limiting toxicities (DLTs) | First cycle of 28 days | Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hematology and chemistry values | From baseline to 28 days after treatment discontinuation | hematology and chemistry values |
| Assessments of physical examinations, vital signs and electrocardiograms (ECGs) | Participants will be followed for the duration of treatment, an expected average of 24 weeks. | — |
| Time vs. concentration profiles | 1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks | To determine the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax, T1/2, etc) of oral BGJ398 including known pharmacologically active metabolites |
| Preliminary anti-tumor activity | Participants will be followed for the duration of treatment, an expected average of 24 weeks. | Assessed based on RECIST version 1.1 |
| Best overall response (BOR) | Participants will be followed for the duration of treatment, an expected average of 24 weeks. | Assessed by investigator per RECIST version 1.1. BOR is the best response recorded until disease progression. |
| Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs) | From within 21 days of first treatment to 28 days after treatment discontinuation | To characterize the safety and tolerability of oral BGJ398 |
| Progression-free survival (PFS) | 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. | 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. |
| Duration of all Adverse Events (AEs) | From within 21 days of first treatment to 28 days after treatment discontinuation | To characterize the safety and tolerability of oral BGJ398 |
| Duration of Serious Advers Events (SAEs) | From within 21 days of first treatment to 28 days after treatment discontinuation | To characterize the safety and tolerability of oral BGJ398 |
| Severity of all Adverse Events (AEs) | From within 21 days of first treatment to 28 days after treatment discontinuation | To characterize the safety and tolerability of oral BGJ398 |
| Severity of all Serious Advers Events (SAEs) | From within 21 days of first treatment to 28 days after treatment discontinuation | To characterize the safety and tolerability of oral BGJ398 |
| Overall response rate (ORR) | Participants will be followed for the duration of treatment, an expected average of 24 weeks. | 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). |
Countries
China, Japan
Outcome results
None listed