Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

July 26, 2013

Primary Completion Date

June 3, 2016

Study Completion Date

June 3, 2016

Conditions
Esophageal Squamous Cell Carcinoma
Interventions
DRUG

LJM716

LJM716 (10-40 mg/kg) will be given as a once weekly infusion beginning on cycle 1 day 1. The doses of LJM716 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established.

DRUG

BYL719

BYL719 (200-400 mg) will be administered orally on a once daily schedule starting cycle 1 day 1. The doses of BYL719 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established.

DRUG

Paclitaxel

In the Phase II portion of the study Paclitaxel is one of the 3 physician's choice drug which allows single-agent paclitaxel to be used per manufacturer's label.

DRUG

Docetaxel

In the Phase II portion of the study Docetaxel is one of the 3 physician's choice drug which allows single-agent docetaxel to be used per manufacturer's label.

DRUG

Irinotecan

In the Phase II portion of the study Irinotecan is one of the 3 physician's choice drug which allows single-agent irinotecan to be used per manufacturer's label

Trial Locations (13)

1200

Novartis Investigative Site, Brussels

10048

Novartis Investigative Site, Taipei

48201

Karmanos Cancer Institute Dept of Onc, Detroit

60637

University of Chicago Medical Center Dept of Onc, Chicago

70421

Novartis Investigative Site, Tainan City

169610

Novartis Investigative Site, Singapore

77030-4009

University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology, Houston

M5G 2M9

Novartis Investigative Site, Toronto

Unknown

Novartis Investigative Site, Hong Kong

03080

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

M20 2BX

Novartis Investigative Site, Manchester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY