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

Completed · Phase 1

Conditions studied: Esophageal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT01822613

Run by

Novartis Pharmaceuticals

People needed

48

Starts

2013-07-26

Expected to finish

2016-06-03

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Chicago Medical Center Dept of Onc — Chicago, Illinois, United States
• Karmanos Cancer Institute Dept of Onc — Detroit, Michigan, United States
• University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology — Houston, Texas, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Tainan, Taiwan ROC, Taiwan
• Novartis Investigative Site — Taipei, Taiwan
• Novartis Investigative Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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