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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01928459