Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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20 June 2016 |
Main ID: |
EUCTR2012-005624-15-ES |
Date of registration:
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16/05/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of safety & efficacy of the combination of LJM716 & BYL719 in patients with previously treated esophageal squamous cell carcinoma (ESCC)
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Scientific title:
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A phase Ib/II, open-label study of LJM716 in combination with BYL719 compared to taxane or irinotecan in patients with previously treated esophageal squamous cell carcinoma |
Date of first enrolment:
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04/07/2013 |
Target sample size:
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100 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005624-15 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Canada
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France
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Hong Kong
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Japan
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Korea, Republic of
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Singapore
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Spain
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Departamento Médico Oncología (GMO)
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Address:
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Gran Via de les Corts Catalanes, 764
08013
Barcelona
Spain |
Telephone:
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+34900353036 |
Email:
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eecc.novartis@novartis.com |
Affiliation:
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Novartis Farmacéutica S.A. |
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Name:
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Departamento Médico Oncología (GMO)
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Address:
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Gran Via de les Corts Catalanes, 764
08013
Barcelona
Spain |
Telephone:
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+34900353036 |
Email:
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eecc.novartis@novartis.com |
Affiliation:
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Novartis Farmacéutica S.A. |
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Key inclusion & exclusion criteria
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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: - 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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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esophageal squamous cell carcinoma
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Intervention(s)
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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: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150-
Product Code: BYL719 Pharmaceutical Form: Tablet INN or Proposed INN: BYL719 CAS Number: BYL719 Current Sponsor code: BYL719 Other descriptive name: BYL719 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-
Product Name: paclitaxel Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Current Sponsor code: PACLITAXEL Other descriptive name: PACLITAXEL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6-
Product Name: docetaxel Pharmaceutical Form: Solution for infusion INN or Proposed INN: DOCETAXEL CAS Number: DOCETAXEL Current Sponsor code: DOCETAXEL Other descriptive name: DOCETAXEL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20-
Product Name: irinotecan Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: IRINOTECAN CAS Number: 97682-44-5 Current Sponsor code: IRINOTECAN Other descriptive name: IRINOTECAN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20-
Product Code: BYL719 Pharmaceutical Form: Tablet INN or Proposed INN: BYL719 CAS Number: BYL719 Current Sponsor code: BYL719 Other descriptive name: BYL719 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Product Code: BYL719 Pharmaceutical Form: Tablet INN or Proposed INN: BYL719 CAS Number: BYL719 Current Sponsor code: BYL719 Other descriptive name: BYL719 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
Product Name: Docetaxel Pharmaceutical Form: Solution for infusion IN
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Primary Outcome(s)
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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
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Secondary Objective: tolerability, PFS, OOS
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Primary end point(s): 1. Phase Ib primary end point: Incidence rate of DLTs. 2. Phase II primary end point: Progression free survival (PFS)
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Timepoint(s) of evaluation of this end point: 1. approximately 8 months 2. Baseline, every 6 weeks until disease progression
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Secondary Outcome(s)
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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 )
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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)
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Secondary ID(s)
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CLJM716X2103
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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