A Phase I Study of Oral BGJ398 in Asian Patients

Study Overview
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Brief Summary
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This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).

Detailed Description
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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.

Official Title
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A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway

Conditions
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Tumor With Alterations of the FGF-R

Intervention / Treatment
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* Drug: BGJ398


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGJ398<br>Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease. | Drug: BGJ398<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate and category of dose limiting toxicities (DLTs) | Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398 | First cycle of 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs) | To characterize the safety and tolerability of oral BGJ398 | From within 21 days of first treatment to 28 days after treatment discontinuation | 
| Changes in hematology and chemistry values | hematology and chemistry values | From baseline to 28 days after treatment discontinuation | 
| 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 | To determine the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax, T1/2, etc) of oral BGJ398 including known pharmacologically active metabolites | 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 | 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. | Participants will be followed for the duration of treatment, an expected average of 24 weeks. | 
| 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). | 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. | 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 | 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 | 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 | 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 | From within 21 days of first treatment to 28 days after treatment discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R