A Phase I Study of Oral BGJ398 in Asian Patients

Phase 1

Completed

• Conditions: Tumor With Alterations of the FGF-R
• Interventions: Drug: BGJ398

• Registration Number: NCT01697605
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Study Start: 2012-10-19
• Primary Completion: 2019-02-07
• Study Completion: 2019-02-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BGJ398	BGJ398	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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).
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.
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
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
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
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.
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
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

Trial Locations

Locations (4)

Nagoya University Hospital; 🇯🇵 Nagoya-city, Aichi, Japan

National Cancer Center Hospital East (NCEE); 🇯🇵 Kashiwa, Chiba, Japan

Shizuoka Cancer Center; 🇯🇵 Sunto-gun, Shizuoka, Japan

Novartis Investigative Site; 🇯🇵 Sayama, Osaka, Japan