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A Phase I Study of Oral BGJ398 in Asian Patients

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ClinicalTrials.gov Identifier: NCT01697605
Recruitment Status : Active, not recruiting
First Posted : October 2, 2012
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Tumor With Alterations of the FGF-R Drug: BGJ398 Phase 1

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  (Clinical Trial)
Actual Enrollment : 9 participants
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
Actual Study Start Date : October 19, 2012
Estimated Primary Completion Date : December 7, 2018
Estimated Study Completion Date : December 7, 2018

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



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Changes in hematology and chemistry values [ Time Frame: From baseline to 28 days after treatment discontinuation ]
    hematology and chemistry values

  3. 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. ]
  4. 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

  5. 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

  6. 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.

  7. 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).

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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



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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.


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


Locations
China, Guangdong
Novartis Investigative Site
Guangzhou, Guangdong, China, 510080
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
China
Novartis Investigative Site
Guangzhou, China, 510060
Japan
Nagoya University Hospital
Nagoya-city, Aichi, Japan, 466-8560
National Cancer Center Hospital East (NCEE)
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site
Sayama, Osaka, Japan, 589-8511
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01697605     History of Changes
Other Study ID Numbers: CBGJ398X1101
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 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