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Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

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ClinicalTrials.gov Identifier: NCT01928459
Recruitment Status : Completed
First Posted : August 26, 2013
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

August 21, 2013
August 26, 2013
August 22, 2017
October 2013
August 2016   (Final data collection date for primary outcome measure)
Incidence rate of dose limiting toxicities (DLTs) of the combination of BGJ398 with BYL719 [ Time Frame: Approximately 8 months ]
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.
Same as current
Complete list of historical versions of study NCT01928459 on ClinicalTrials.gov Archive Site
  • 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 ]
    This will be assessed by looking at the number of Adverse Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions and reductions
  • Overall response rate [ Time Frame: Every two months from the date of baseline CT scan ]
    Assessment of preliminary antitumor activity of the combination of BGJ398 with BYL719; Overall response rate = complete response + partial response
  • Progression free survival [ Time Frame: Every two months from the date of baseline CT scan ]
    Assessment of preliminary antitumor activity of the combination of BGJ398 with BYL719
  • Time vs. concentration profile of BGJ398 and BYL719 [ Time Frame: Every 28 days for up to 10 cycles ]
    Plasma concentration versus time profiles. Plasma PK parameters will be used to characterize the PK profiles of the combination of BGJ398 with BYL719
Same as current
Not Provided
Not Provided
 
Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
A Phase Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors
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.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Advanced Solid Tumors
  • Metastatic Solid Tumors
  • Drug: BGJ398
    BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
  • Drug: BYL719
    BYL719 will be administered orally once daily on each day of the 28-day cycle.
  • 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.
    Interventions:
    • Drug: BGJ398
    • Drug: BYL719
  • Experimental: Solid tumor arm 1
    Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA.
    Interventions:
    • Drug: BGJ398
    • Drug: BYL719
  • 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
    Interventions:
    • Drug: BGJ398
    • Drug: BYL719
  • 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.
    Interventions:
    • Drug: BGJ398
    • Drug: BYL719
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
55
August 2016
August 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Singapore,   Spain,   Switzerland,   United States
United Kingdom
 
NCT01928459
CBGJ398X2102
No
Not Provided
Plan to Share IPD: No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP