NCT01928459

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 Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2013

Typical duration for phase_1

Geographic Reach
12 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 9, 2020

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

August 21, 2013

Last Update Submit

December 6, 2020

Conditions

Advanced Solid TumorsMetastatic Solid Tumors

Keywords

BGJ398BYL719advanced solid tumormetastatic breast cancerPK3CAFGFRfibroblast growth factor receptor

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of dose limiting toxicities (DLTs) of the combination of BGJ398 with BYL719

    The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or the recommended dose for expansion (RDE). Safety(incidence and nature of DLTs), pharmacokinetic and pharmacodynamic data will guide dose escalation decisioins.

    Approximately 8 months

Secondary Outcomes (4)

  • Safety and tolerability of BGJ398/BYL719 combination at the recommended dose for expansion (RDE)

    Every 28 days from baseline visit until end of study visit

  • Overall response rate

    Every two months from the date of baseline CT scan

  • Progression free survival

    Every two months from the date of baseline CT scan

  • Time vs. concentration profile of BGJ398 and BYL719

    Every 28 days for up to 10 cycles

Study Arms (4)

Metastatic breast cancer

EXPERIMENTAL

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

Drug: BGJ398Drug: BYL719

Solid tumor arm 1

EXPERIMENTAL

Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA.

Drug: BGJ398Drug: BYL719

Solid tumor arm 2

EXPERIMENTAL

Patients with solid tumors (except for colorectal cancer) whose tumomrs express mutations to PIK3CA and alterations to FGFR 1-3

Drug: BGJ398Drug: BYL719

Dose escalation

EXPERIMENTAL

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.

Drug: BGJ398Drug: BYL719

Interventions

BGJ398DRUG

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

Dose escalationMetastatic breast cancerSolid tumor arm 1Solid tumor arm 2
BYL719DRUG

BYL719 will be administered orally once daily on each day of the 28-day cycle.

Dose escalationMetastatic breast cancerSolid tumor arm 1Solid tumor arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

H. Lee Moffitt Cancer Center & Research Institute Moffitt 4

Tampa, Florida, 33612, United States

Location

University of Michigan Comprehensive Cancer Center SC

Ann Arbor, Michigan, 48109-0944, United States

Location

Karmanos Cancer Institute Dept of Onc

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine Onc Dept

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center Onc Dept

New York, New York, 10065, United States

Location

Vanderbilt University Medical Center Dept of Onc

Nashville, Tennessee, 37232, United States

Location

Cancer Therapy & Research Center / UT Health Science Center SC

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Parkville, Victoria, 3050, Australia

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Saint-Herblain, 44805, France

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Modena, MO, 41100, Italy

Location

Novartis Investigative Site

Amsterdam, 1066 CX, Netherlands

Location

Novartis Investigative Site

Singapore, 169610, Singapore

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Seville, Andalusia, 41013, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Madrid, 28050, Spain

Location

Novartis Investigative Site

Bellinzona, 6500, Switzerland

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsAcrocephalosyndactylia

Interventions

infigratinibAlpelisib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCraniosynostosesSynostosisDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesSyndactylyCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesLimb Deformities, CongenitalCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 26, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 9, 2020

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(7)DE(1)AU(1)BE(1)NL(1)FR(2)SG(1)CA(1)IT(2)KR(1)CH(1)ES(3)