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A Phase I Study of Oral BGJ398 in Asian Patients

This study is currently recruiting participants.
Verified September 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697605
First Posted: October 2, 2012
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).

Condition Intervention Phase
Tumor With Alterations of the FGF-R Drug: BGJ398 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Incidence rate and category of dose limiting toxicities (DLTs) [ Time Frame: First cycle of 28 days ]
    Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398


Secondary Outcome Measures:
  • Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs) [ Time Frame: 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 [ Time Frame: From baseline to 28 days after treatment discontinuation ]
    hematology and chemistry values

  • Assessments of physical examinations, vital signs and electrocardiograms (ECGs) [ Time Frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks. ]
  • Time vs. concentration profiles [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: From within 21 days of first treatment to 28 days after treatment discontinuation ]
    To characterize the safety and tolerability of oral BGJ398


Estimated Enrollment: 22
Actual Study Start Date: October 19, 2012
Estimated Study Completion Date: December 7, 2017
Estimated Primary Completion Date: December 7, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697605


Contacts
Contact: Novartis Pharmaceuticals +41613241111 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +81337978748

Locations
China, Guangdong
Novartis Investigative Site Completed
Guangzhou, Guangdong, China, 510080
China, Sichuan
Novartis Investigative Site Completed
Chengdu, Sichuan, China, 610041
China
Novartis Investigative Site Active, not recruiting
Guangzhou, China, 510060
Japan
Nagoya University Hospital Recruiting
Nagoya-city, Aichi, Japan, 466-8560
National Cancer Center Hospital East (NCEE) Recruiting
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site Completed
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site Completed
Sayama, Osaka, Japan, 589-8511
Shizuoka Cancer Center Recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01697605     History of Changes
Other Study ID Numbers: CBGJ398X1101
First Submitted: September 19, 2012
First Posted: October 2, 2012
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R