esophageal squamous cell carcinoma
Conditions
Interventions
Product Code: LJM716
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: LJM716
CAS Number: LJM716
Current Sponsor code: LJM716
Other descriptive name: LJM716
Concentration unit
Sponsors
Novartis Farmacéutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed 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 platinumbased chemotherapy or chemoradiotherapy for localized disease. Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 62 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: - Patients who received prior PI3K inhibitor or anti-HER3 antibody treatment, including bi-specific antibodies with HER3 as one of the targets (patients with prior exposure to pertuzumab or 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 sytem (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 exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician?s choice in previously treated ESCC patients;Secondary Objective: tolerability, PFS, OOS;Primary end point(s): 1. Phase Ib primary end point: Incidence rate of DLTs. 2. Phase II primary end point: Progression free survival (PFS);Timepoint(s) of evaluation of this end point: 1. approximately 8 months 2. Baseline, every 6 weeks until disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety and tolerability of the LJM716-BYL719 2. Best overall response (BOR), per RECIST 1.1 (Ph 1b ) 3. Plasma concentration versus time profiles; Plasma PK parameters of LJM716, BYL719 4. Overall response rate (ORR) per RECIST 1.1 (Ph 1b ) 5. Duration of response (DOR) per RECIST 1.1 (Ph 1b ) 6. Disease control rate (DCR) per RECIST 1.1 (Ph 1b ) 7. Overall survival (OS) per RECIST 1.1 (for Ph 1b ) 8. Progression free survival (PFS) per RECIST 1.1 (Ph 1b );Timepoint(s) of evaluation of this end point: 1. Baseline, every 21 days until end of study (about 5 months) 2. Baseline, every 21 days until end of treatment (about 4 months) 3. Baseline, 2hr,4hr,8hr,24hr,48hr,96hr, 168 hr, every 21 days for 10 cycles (21 days each) and at end of treatment (about 4 months) 4-6. Baseline, every 21 days until end of treatment (about 4 months) 7-8. Baseline, every 21 days until end of study (about 5 months) | — |
Countries
Belgium, Canada, France, Hong Kong, Japan, Korea, Republic of, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactDepartamento Médico Oncología (GMO)
Novartis Farmacéutica S.A.
Outcome results
None listed