Phase 1b trial of BGJ398/BYL719 in solid tumors

Phase 1

Conditions: Advanced solid tumors,metastatic solid tumors
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-001018-14-DE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 55

Inclusion Criteria

• Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anticancer 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
other, protocol-defined criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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
other, protocol-defined criteria may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: tolerability, ORR, PFS;Primary end point(s): Incidence rate of dose limiting toxicities (DLTs) of the combination of BGJ398 with BYL719;Timepoint(s) of evaluation of this end point: approx. 8 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Safety and tolerability of BGJ398/BYL719 combination at the recommended dose for expansion (RDE)<br>2. Overall response rate<br>3. Progression free survival<br>4. Time vs. concentration profile of BGJ398 and BYL719;Timepoint(s) of evaluation of this end point: 1. Every 28 days from baseline visit until end of study visit<br>2 and 3. Every two months from the date of baseline CT scan<br>4. Every 28 days for up to 10 cycles