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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01004224




Registration number
NCT01004224
Ethics application status
Date submitted
27/10/2009
Date registered
29/10/2009
Date last updated
4/10/2019

Titles & IDs
Public title
A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
Scientific title
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
Secondary ID [1] 0 0
2009-010876-73
Secondary ID [2] 0 0
CBGJ398X2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3 0 0
Squamous Lung Cancer With FGFR1 Amplification 0 0
Bladder Cancer With FGFR3 Mutation or Fusion 0 0
Advanced Solid Tumors With FGFR1 Amplication 0 0
Advanced Solid Tumors With FGFR2 Amplication 0 0
Advanced Solid Tumors With FGFR3 Mutation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: BGJ398 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
23 months
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
23 months
Secondary outcome [2] 0 0
To determine the pharmacokinetic (PK) profiles of oral BGJ398
Timepoint [2] 0 0
23 months
Secondary outcome [3] 0 0
To evaluate the pharmacodynamic effect of the drug.
Timepoint [3] 0 0
23 months
Secondary outcome [4] 0 0
Assess preliminary anti-tumor activity for patients not in Arm 4.
Timepoint [4] 0 0
23 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/10/2018
Sample size
Target
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
Austria
State/province [11] 0 0
Vienna
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux Cedex
Country [13] 0 0
France
State/province [13] 0 0
Lyon Cedex
Country [14] 0 0
France
State/province [14] 0 0
Marseille
Country [15] 0 0
France
State/province [15] 0 0
Montpellier Cedex 5
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Saint-Herblain Cédex
Country [18] 0 0
France
State/province [18] 0 0
Suresnes
Country [19] 0 0
France
State/province [19] 0 0
Toulouse Cedex 9
Country [20] 0 0
France
State/province [20] 0 0
Villejuif Cedex
Country [21] 0 0
Germany
State/province [21] 0 0
Nordrhein-Westfalen
Country [22] 0 0
Germany
State/province [22] 0 0
Essen
Country [23] 0 0
Germany
State/province [23] 0 0
Hannover
Country [24] 0 0
Germany
State/province [24] 0 0
Marburg
Country [25] 0 0
Israel
State/province [25] 0 0
Ramat Gan
Country [26] 0 0
Israel
State/province [26] 0 0
Tel Aviv
Country [27] 0 0
Italy
State/province [27] 0 0
FC
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Korea
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Netherlands
State/province [30] 0 0
Amsterdam
Country [31] 0 0
Singapore
State/province [31] 0 0
Singapore
Country [32] 0 0
Spain
State/province [32] 0 0
Andalucia
Country [33] 0 0
Spain
State/province [33] 0 0
Catalunya
Country [34] 0 0
Spain
State/province [34] 0 0
Comunidad Valenciana
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei
Country [38] 0 0
Thailand
State/province [38] 0 0
Bangkok
Country [39] 0 0
Thailand
State/province [39] 0 0
Chiang Mai
Country [40] 0 0
Turkey
State/province [40] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.
Trial website
https://clinicaltrials.gov/study/NCT01004224
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01004224