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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.
- 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
H. Lee Moffitt Cancer Center & Research Institute Onc Dept.
Status: Withdrawn
Tampa, Florida, United States
University of Chicago Medical Center Dept of Onc
Status: Withdrawn
Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Dept of Onc.
Status: Active, not recruiting
Baltimore, Maryland, United States
Karmanos Cancer Institute Dept of Onc
Status: Completed
Detroit, Michigan, United States
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Status: Completed
Houston, Texas, United States
Novartis Investigative Site
Status: Recruiting
Contact: Silvia Wiltz-Bell - 713-745-3917 - sbell@mdanderson.org
Bruxelles, Belgium
Novartis Investigative Site
Status: Active, not recruiting
Vancouver, British Columbia, Canada
Novartis Investigative Site
Status: Withdrawn
Toronto, Ontario, Canada
Novartis Investigative Site
Status: Completed
Dijon Cedex, France
Novartis Investigative Site
Status: Withdrawn
Saint Herblain cedex, France
Novartis Investigative Site
Status: Withdrawn
Villejuif Cedex, France
Novartis Investigative Site
Status: Withdrawn
Hong Kong, Hong Kong
Novartis Investigative Site
Status: Recruiting
Seoul, Korea, Korea, Republic of
Novartis Investigative Site
Status: Completed
Seoul, Korea, Korea, Republic of
Novartis Investigative Site
Status: Completed
Singapore, Singapore
Novartis Investigative Site
Status: Withdrawn
Singapore, Singapore
Novartis Investigative Site
Status: Recruiting
Santander, Cantabria, Spain
Novartis Investigative Site
Status: Completed
Barcelona, Catalunya, Spain
Novartis Investigative Site
Status: Completed
Madrid, Spain
Novartis Investigative Site
Status: Completed
Tainan 704, Taiwan ROC, Taiwan
Novartis Investigative Site
Status: Recruiting
Taipei, Taiwan
Novartis Investigative Site
Status: Recruiting
Glasgow, United Kingdom
Novartis Investigative Site
Status: Recruiting
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