A Phase I Study of Oral BGJ398 in Asian Patients

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

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

Study Overview

• Status: Completed
• Conditions: Tumor With Alterations of the FGF-R
• Intervention / Treatment: Drug: BGJ398

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510060
    • Novartis Investigative Site
  • Guangdong
    • Guangzhou, Guangdong, China, 51000
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Novartis Investigative Site
• Japan
  • Aichi
    • Nagoya-city, Aichi, Japan, 466-8560
      • Nagoya University Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East (NCEE)
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Novartis Investigative Site
  • Osaka
    • Sayama, Osaka, Japan, 589 8511
      • Novartis Investigative Site
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: BGJ398

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CBGJ398X1101 can be found on the Novartis Clinical Trials Results website

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2012
• Primary Completion (Actual): February 7, 2019
• Study Completion (Actual): February 7, 2019

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R
• Additional Relevant MeSH Terms: Antineoplastic Agents; Infigratinib
• Other Study ID Numbers: CBGJ398X1101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No