A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

October 2, 2019 updated by: Novartis Pharmaceuticals

A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral BGJ398, a Pan FGF-R Kinase Inhibitor, in Adult Patients With Advanced Solid Malignancies

The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Novartis Investigative Site
  • Austria
      • Vienna, Austria, A-1100
        • Novartis Investigative Site
  • France
      • Bordeaux Cedex, France, 33075
        • Novartis Investigative Site
      • Lyon Cedex, France, 69373
        • Novartis Investigative Site
      • Marseille, France, 13273
        • Novartis Investigative Site
      • Montpellier Cedex 5, France, 34298
        • Novartis Investigative Site
      • Paris, France, 75015
        • Novartis Investigative Site
      • Saint-Herblain Cédex, France, 44805
        • Novartis Investigative Site
      • Suresnes, France, 92150
        • Novartis Investigative Site
      • Toulouse Cedex 9, France, 31059
        • Novartis Investigative Site
      • Villejuif Cedex, France, 94805
        • Novartis Investigative Site
  • Germany
      • Essen, Germany, 45147
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Marburg, Germany, 35039
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Koeln, Nordrhein-Westfalen, Germany, 50937
        • Novartis Investigative Site
  • Israel
      • Ramat Gan, Israel, 5265601
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Novartis Investigative Site
  • Italy
    • FC
      • Meldola, FC, Italy, 47014
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 05505
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Novartis Investigative Site
      • Amsterdam, Netherlands, 1081 HV
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169610
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28050
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Novartis Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spain, 41013
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46009
        • Novartis Investigative Site
  • Taiwan
      • Taipei, Taiwan, 10048
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
  • Turkey
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
  • United States
    • California
      • Duarte, California, United States, 91010 3000
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90033
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90095
        • Novartis Investigative Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Dept. of Anschutz Cancer (3)
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Novartis Investigative Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10029
        • Novartis Investigative Site
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center Onc. Dept..
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, United States, 19107-5098
        • Thomas Jefferson University Hospital Onc Dept
      • Pittsburgh, Pennsylvania, United States, 15232
        • Novartis Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Novartis Investigative Site
      • Nashville, Tennessee, United States, 37203
        • Novartis Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
  • Adequate bone marrow function
  • Adequate hepatic and renal function
  • Adequate cardiovascular function

  • Contraception.

    • For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
    • For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period

Exclusion Criteria:

  • Patients with primary CNS tumor or CNS tumor involvement
  • Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
  • History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
  • Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
  • History or current evidence of cardiac arrhythmia and/or conduction abnormality
  • Women who are pregnant or nursing.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BGJ398
Drug: BGJ398

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD)
Time Frame: 23 months
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD). This will be calculated using an established statistical model, based on incidence of adverse events and serious adverse events, physical examinations, vital signs, electrocardiograms, and laboratory parameters
23 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess preliminary anti-tumor activity of BGJ398 for patients in expansion Arm 4 (previously treated patients with advanced/metastatic UCC with FGFR3 gene alterations)
Time Frame: 23 months
overall response rate (ORR), as assessed by investigator per RECIST v 1.0; overall survival (OS), duration of response (DOR) and disease control rate (DCR) will be assessed
23 months
To determine the pharmacokinetic (PK) profiles of oral BGJ398
Time Frame: 23 months
Time vs. concentration profiles, PK parameters of BGJ398 and known active metabolite(s).
23 months
To evaluate the pharmacodynamic effect of the drug.
Time Frame: 23 months
Pre- vs. post treatment serial changes in FGF23 plasma levels (not done for patients enrolled to expansion Arm 4)
23 months
Assess preliminary anti-tumor activity for patients not in Arm 4.
Time Frame: 23 months
Overall tumor response rate (ORR) and PFS assessed by investigator per RECIST
23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 11, 2009

Primary Completion (ACTUAL)

October 8, 2018

Study Completion (ACTUAL)

October 8, 2018

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (ESTIMATE)

October 29, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBGJ398X2101
  • 2009-010876-73 (EUDRACT_NUMBER)

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

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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