Phase 1b Trial of BGJ398/BYL719 in Solid Tumors



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/18/2016
Start Date:October 2013
End Date:August 2016

Use our guide to learn which trials are right for you!

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.

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
We found this trial at
8
sites
Nashville, Tennessee 37232
Principal Investigator: Ingrid A. Mayer
Phone: 615-343-0798
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
Principal Investigator: Rashmi Chugh
Phone: 734-232-0759
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Detroit, Michigan 48201
Principal Investigator: Ulka M. Vaishampayan
Phone: +1 313 576 8096
?
mi
from
Detroit, MI
Click here to add this to my saved trials
NY, New York 90033
Principal Investigator: David G. Hyman
Phone: 646-227-3206
?
mi
from
NY, NY
Click here to add this to my saved trials
Parkville, Victoria
?
mi
from
Parkville,
Click here to add this to my saved trials
San Antonio, Texas 78229
Principal Investigator: John Sarantopoulos
Phone: 210-450-5976
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
St. Louis, Missouri 63110
Principal Investigator: Craig X. Lockhart
Phone: 314-362-7249
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Tampa, Florida 33612
Principal Investigator: Amit Mahipal
Phone: 813-745-5434
?
mi
from
Tampa, FL
Click here to add this to my saved trials