Overview

This trial is active, not recruiting.

Conditions advanced solid tumors,, metastatic solid tumors
Treatments bgj398, byl719
Phase phase 1
Targets FGFR, PI3K
Sponsor Novartis Pharmaceuticals
Start date October 2013
End date August 2016
Trial size 61 participants
Trial identifier NCT01928459, CBGJ398X2102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Evaluation of safety and efficacy in patients with metastatic breast cancer whose tumors contain mutations to PIK3CA and alterations FGFR 1-3.
bgj398
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
byl719
BYL719 will be administered orally once daily on each day of the 28-day cycle.
(Experimental)
Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA.
bgj398
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
byl719
BYL719 will be administered orally once daily on each day of the 28-day cycle.
(Experimental)
Patients with solid tumors (except for colorectal cancer) whose tumomrs express mutations to PIK3CA and alterations to FGFR 1-3
bgj398
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
byl719
BYL719 will be administered orally once daily on each day of the 28-day cycle.
(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.
bgj398
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
byl719
BYL719 will be administered orally once daily on each day of the 28-day cycle.

Primary Outcomes

Measure
Incidence rate of dose limiting toxicities (DLTs) of the combination of BGJ398 with BYL719
time frame: Approximately 8 months

Secondary Outcomes

Measure
Safety and tolerability of BGJ398/BYL719 combination at the recommended dose for expansion (RDE)
time frame: Every 28 days from baseline visit until end of study visit
Overall response rate
time frame: Every two months from the date of baseline CT scan
Progression free survival
time frame: Every two months from the date of baseline CT scan
Time vs. concentration profile of BGJ398 and BYL719
time frame: Every 28 days for up to 10 cycles

Eligibility Criteria

Male or female participants at least 18 years old.

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 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

Additional Information

Official title A Phase Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors
Description This dose escalation/dose expansion study will evaluate the combination of orally administered BGJ398 in combination with orally administered BYL719. During the dose escalation part, the MTD of the combination will be determined in patients whose advanced or metastatic tumors express mutations to PIK3CA. Once the MTD has been determined, the expansion part will begin. Patients will be addd to one of three arms based on the disease type and genetic changes. Patients with metastatic colorectal cancer are not eligible for participation in the expansion part.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novartis.
Location data was received from the National Cancer Institute and was last updated in August 2016.