Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Phase I Study of Oral BGJ398 in Asian Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01697605
First received: September 19, 2012
Last updated: May 19, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence rate and category of dose limiting toxicities (DLTs) [ Time Frame: First cycle of 28 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    To characterize the safety and tolerability of oral BGJ398


Estimated Enrollment: 41
Study Start Date: October 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697605

Contacts
Contact: Novartis Pharmaceuticals +81337978748
Contact: Novartis Pharmaceuticals

Locations
Japan
Novartis Investigative Site Recruiting
Nagoya-city, Aichi, Japan, 466-8560
Novartis Investigative Site Recruiting
Kashiwa, Chiba, Japan
Novartis Investigative Site Recruiting
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site Recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01697605     History of Changes
Other Study ID Numbers: CBGJ398X1101
Study First Received: September 19, 2012
Last Updated: May 19, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on November 27, 2014