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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14 July 2014 |
Main ID: |
EUCTR2011-005875-17-IT |
Date of registration:
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27/02/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase Ib/II study of LGX818 in combination with MEK162 in adult patients with BRAF dependent advanced solid tumors
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Scientific title:
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A Phase Ib/II, multicenter, open-label, dose escalation study of LGX818 in combination with MEK162 in adult patients with BRAF V600 - dependent advanced solid tumors |
Date of first enrolment:
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15/04/2013 |
Target sample size:
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127 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005875-17 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Australia
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Canada
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Italy
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Singapore
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Spain
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Switzerland
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United States
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Contacts
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Name:
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Drug Regulatroy Affairs
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Address:
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Largo Umberto Boccioni, 1
2040
ORIGGIO (VA)
Italy |
Telephone:
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+390296541 |
Email:
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info.studiclinici@novartis.com |
Affiliation:
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NOVARTI FARMA S.p.A. |
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Name:
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Drug Regulatroy Affairs
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Address:
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Largo Umberto Boccioni, 1
2040
ORIGGIO (VA)
Italy |
Telephone:
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+390296541 |
Email:
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info.studiclinici@novartis.com |
Affiliation:
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NOVARTI FARMA S.p.A. |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Age = 18 years for both phases and arms
• Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or confirmed diagnosis of non-resectable advanced metastatic colorectal cancer (mCRC), or any other indication upon agreement with the Sponsor, whose disease has progressed despite previous antineoplastic therapy or for whom no further effective standard therapy is available.
• Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.
• Evidence of measurable disease as determined by RECIST v1.1.
• World Health Organization (WHO) Performance Status = 2.
• Negative serum pregnancy test within 72 hours prior to the first study
dose in all women of childbearing potential.
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 114 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria: • Progressive disease following prior treatment with RAF-inhibitors in combination with MEK-inhibitors.
• Symptomatic or untreated leptomeningeal disease.
• Symptomatic brain metastases. Patients are not permitted to receive enzyme inducing anti-epileptic drugs.
• Known acute or chronic pancreatitis.
• History or current evidence of retinal disease, retinal vein occlusion or ophthalmopathy.
• Clinically significant cardiac disease.
• Patients with abnormal laboratory values at Screening/baseline.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818/MEK162
• Previous or concurrent malignancy.
• Pregnant or nursing (lactating) women.
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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Patients with solid tumors harboring a BRAF V600 mutation. MedDRA version: 15.1
Level: PT
Classification code 10052358
Term: Colorectal cancer metastatic
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 15.1
Level: PT
Classification code 10027480
Term: Metastatic malignant melanoma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Product Code: LGX818 Pharmaceutical Form: Capsule, hard CAS Number: 1269440-17-6 Current Sponsor code: LGX818 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-
Product Code: MEK162 Pharmaceutical Form: Film-coated tablet CAS Number: 606143-89-9 Current Sponsor code: MEK162 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15-
Product Code: LGX818 Pharmaceutical Form: Capsule, hard CAS Number: 1269440-17-6 Current Sponsor code: LGX818 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-
Product Code: LGX818 Pharmaceutical Form: Capsule, hard CAS Number: 1269440-17-6 Current Sponsor code: LGX818 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Product Code: LGX818 Pharmaceutical Form: Capsule, hard CAS Number: 1269440-17-6 Current Sponsor code: LGX818 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Main Objective: Phase Ib: To estimate the MTD(s) and/or RP2D(s) of oral LGX818 in combination with oral MEK162 in patients with BRAF V600-dependent advanced solid tumors. Phase II: To assess clinical efficacy of the LGX818 and MEK162 combination in the Phase II populations.
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Primary end point(s): Phase Ib: Incidence of Dose Limiting Toxicities
Phase II : Disease control rate (DCR) as per RECIST v1.1 OR Objective Response Rate (ORR) as per RECIST v1.1 (depending on arm)
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Timepoint(s) of evaluation of this end point: Phase Ib : up to 8 months Phase II : up to 14 months
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Secondary Objective: 1. Phase Ib and II : to characterize the safety and tolerability of LGX818 and MEK162 in combination. 2. Phase Ib : to determine the single and multiple dose PK profile of the LGX818 and MEK162 combination. 3. Phase Ib : to assess preliminary anti-tumor activity of the LGX818 and MEK162 combination. 4. Phase II : to further assess clinical efficacy of the LGX818 and MEK162 combination in the Phase II populations.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1. up to 17 months
2. up to 8 months
3. up to 8 months
4. up to 14 months
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Secondary end point(s): 1. Phase Ib and II : Incidence and severity (as per CTCAE grading) of AEs.
2. Phase Ib : Plasma concentrations of MEK162 and LGX818 respectively at different timepoints prior and post study drug combination dosing on several days within Cycle 1 and subsequent cycles.
3. Phase Ib : ORR as per RECIST v1.1
4. Phase II : Progression Free Survival (PFS) as per RECIST 1.1 in all patients with the same indication
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Secondary ID(s)
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2011-005875-17-ES
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CMEK162X2110
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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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