Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)
Conditions
Esophageal Squamous Cell Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
esophageal cancer
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: LJM716 Type: Drug
Name: BYL719 Type: Drug
Name: Paclitaxel Type: Drug
Name: Docetaxel Type: Drug
Name: Irinotecan Type: Drug
Overall Status
Recruiting
Summary
To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically confirmed esophageal squamous cell carcinoma (ESCC)

- No more than one prior chemotherapy regimen for recurrent or metastatic ESCC (for Phase II only).

- Progression during or after platinum-based therapy for recurrent or metastatic ESCC, or recurrence within 6 months of platinum-based chemotherapy or chemoradiotherapy for localized disease.

Exclusion Criteria:

- Patients who received prior phosphoinositide-3-kinase (PI3K) inhibitor or anti-receptor tyrosine-protein kinase erbB-3 (ERBB3 or HER3) antibody treatment, including bi-specific antibodies with HER3 as one of the targets (patients with prior exposure to pertuzumab or epidermal growth factor receptor (EGFR)-targeted agents are eligible)

- Patients who do not have an archival or fresh tumor sample (or sections of it) available or readily obtainable.

- Patients with central nervous system (CNS) metastatic involvement.

- Patients who have received prior systemic anti-cancer treatment, such as cyclical chemotherapy or biological therapy within a period of time that is shorter than the cycle length used for that treatment (e.g. 6 weeks for nitrosourea, mitomycin-C) prior to starting study treatment.

- Patients who have received definitive radiotherapy ≤ 4 weeks prior to starting study drug, who have not recovered from side effects of such therapy and/or from whom ≥ 30% of the bone marrow was irradiated.

- Other protocol-defined inclusion/exclusion criteria may apply.
Locations
University of California at Los Angeles Dept of Onc
Los Angeles, California, United States
Status: Withdrawn
H. Lee Moffitt Cancer Center & Research Institute Onc Dept.
Tampa, Florida, United States
Status: Withdrawn
University of Chicago Medical Center Dept of Onc
Chicago, Illinois, United States
Status: Active, not recruiting
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Dept of Onc.
Baltimore, Maryland, United States
Status: Completed
Karmanos Cancer Institute Dept of Onc
Detroit, Michigan, United States
Status: Completed
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Houston, Texas, United States
Status: Recruiting
Contact: Silvia Wiltz-Bell - 713-745-3917 - sbell@mdanderson.org
Novartis Investigative Site
Bruxelles, Belgium
Status: Active, not recruiting
Novartis Investigative Site
Vancouver, British Columbia, Canada
Status: Withdrawn
Novartis Investigative Site
Toronto, Ontario, Canada
Status: Completed
Novartis Investigative Site
Dijon Cedex, France
Status: Withdrawn
Novartis Investigative Site
Saint Herblain cedex, France
Status: Withdrawn
Novartis Investigative Site
Villejuif Cedex, France
Status: Withdrawn
Novartis Investigative Site
Hong Kong, Hong Kong
Status: Recruiting
Novartis Investigative Site
Seoul, Korea, Korea, Republic of
Status: Completed
Novartis Investigative Site
Seoul, Korea, Korea, Republic of
Status: Completed
Novartis Investigative Site
Singapore, Singapore
Status: Withdrawn
Novartis Investigative Site
Singapore, Singapore
Status: Recruiting
Novartis Investigative Site
Santander, Cantabria, Spain
Status: Completed
Novartis Investigative Site
Barcelona, Catalunya, Spain
Status: Completed
Novartis Investigative Site
Madrid, Spain
Status: Completed
Novartis Investigative Site
Tainan 704, Taiwan ROC, Taiwan
Status: Recruiting
Novartis Investigative Site
Taipei, Taiwan
Status: Recruiting
Novartis Investigative Site
Glasgow, United Kingdom
Status: Recruiting
Novartis Investigative Site
Manchester, United Kingdom
Status: Recruiting
Start Date
July 2013
Completion Date
March 2016
Sponsors
Novartis Pharmaceuticals
Source
Novartis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page