A Phase I Study of Oral BGJ398 in Asian Patients

NCT01697605 | Completed Phase 1

• 1 other identifier: CBGJ398X1101
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 8

Brief Summary

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

Conditions

Tumor With Alterations of the FGF-R

Keywords

Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)

  From within 21 days of first treatment to 28 days after treatment discontinuation

• Changes in 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

  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

  Participants will be followed for the duration of treatment, an expected average of 24 weeks.

Study Arms (1)

BGJ398

EXPERIMENTAL

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

Interventions

BGJ398 DRUG

BGJ398

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced solid tumors with FGF-R alteration
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate organ function

You may not qualify if:

• Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease
• Pregnant or nursing (lactating) women

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Guangzhou, Guangdong, 51000, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Guangzhou, 510060, China

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

National Cancer Center Hospital East (NCEE)

Kashiwa, Chiba, 277-8577, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Sayama, Osaka, 589 8511, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Related Links

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

MeSH Terms

Interventions

infigratinib

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: October 2, 2012
• Study Start: October 19, 2012
• Primary Completion: February 7, 2019
• Study Completion: February 7, 2019
• Last Updated: December 8, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3); JP (5)