Status:
COMPLETED
Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
The study design included a Phase 1b dose escalation portion to define the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) for the combination of LJM716 and alpelisib, followed by an open...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01822613
Start Date
July 26 2013
End Date
June 3 2016
Last Update
December 19 2020
Active Locations (13)
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1
University of Chicago Medical Center Dept of Onc
Chicago, Illinois, United States, 60637
2
Karmanos Cancer Institute Dept of Onc
Detroit, Michigan, United States, 48201
3
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Houston, Texas, United States, 77030-4009
4
Novartis Investigative Site
Brussels, Belgium, 1200