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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01928459




Registration number
NCT01928459
Ethics application status
Date submitted
21/08/2013
Date registered
26/08/2013
Date last updated
9/12/2020

Titles & IDs
Public title
Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
Scientific title
A Phase Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors
Secondary ID [1] 0 0
CBGJ398X2102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGJ398
Treatment: Drugs - BYL719

Experimental: Metastatic breast cancer - Evaluation of safety and efficacy in patients with metastatic breast cancer whose tumors contain mutations to PIK3CA and alterations FGFR 1-3.

Experimental: Solid tumor arm 1 - Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA.

Experimental: Solid tumor arm 2 - Patients with solid tumors (except for colorectal cancer) whose tumomrs express mutations to PIK3CA and alterations to FGFR 1-3

Experimental: Dose escalation - To determine the MTD or RDE of the combination of BGJ398 with BYL719 in patients with advanced or metastastic solid tumors that express mutations to PIK3CA.


Treatment: Drugs: BGJ398
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.

Treatment: Drugs: BYL719
BYL719 will be administered orally once daily on each day of the 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence rate of dose limiting toxicities (DLTs) of the combination of BGJ398 with BYL719
Timepoint [1] 0 0
Approximately 8 months
Secondary outcome [1] 0 0
Safety and tolerability of BGJ398/BYL719 combination at the recommended dose for expansion (RDE)
Timepoint [1] 0 0
Every 28 days from baseline visit until end of study visit
Secondary outcome [2] 0 0
Overall response rate
Timepoint [2] 0 0
Every two months from the date of baseline CT scan
Secondary outcome [3] 0 0
Progression free survival
Timepoint [3] 0 0
Every two months from the date of baseline CT scan
Secondary outcome [4] 0 0
Time vs. concentration profile of BGJ398 and BYL719
Timepoint [4] 0 0
Every 28 days for up to 10 cycles

Eligibility
Key inclusion criteria
* Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy exists
* Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)
* Measurable disease defined by RECIST v1.1
* ECOG performance status of =2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part)
* Colorectal cancer (for patients enrolled to expansion part)
* Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose = 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus
* Use of medications that increase serum levels of phosphorus and/or calcium
* Inorganic phosphorus outside of normal limits
* Total and ionized serum calcium outside of normal limits

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
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2016
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Belgium
State/province [7] 0 0
Bruxelles
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
France
State/province [9] 0 0
Lyon Cedex
Country [10] 0 0
France
State/province [10] 0 0
Saint Herblain cedex
Country [11] 0 0
Germany
State/province [11] 0 0
Nordrhein-Westfalen
Country [12] 0 0
Italy
State/province [12] 0 0
MI
Country [13] 0 0
Italy
State/province [13] 0 0
MO
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Korea
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Singapore
State/province [16] 0 0
Singapore
Country [17] 0 0
Spain
State/province [17] 0 0
Andalucia
Country [18] 0 0
Spain
State/province [18] 0 0
Catalunya
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Switzerland
State/province [20] 0 0
Bellinzona

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

Ethics approval
Ethics application status

Summary
Brief summary
To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.
Trial website
https://clinicaltrials.gov/study/NCT01928459
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/NCT01928459