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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17 October 2016 |
Main ID: |
EUCTR2010-023526-21-DK |
Date of registration:
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05/09/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanoma
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Scientific title:
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An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanoma |
Date of first enrolment:
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13/09/2011 |
Target sample size:
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2000 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023526-21 |
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
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Albania
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Argentina
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Australia
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Austria
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Belgium
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Bosnia and Herzegovina
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Brazil
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Bulgaria
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Canada
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Chile
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Colombia
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Croatia
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Czech Republic
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Denmark
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Ecuador
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Estonia
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Finland
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Germany
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Greece
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Hungary
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India
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Ireland
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Israel
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Italy
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Korea, Republic of
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Latvia
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Lithuania
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Macedonia, the former Yugoslav Republic of
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Mexico
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Netherlands
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Norway
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Peru
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Slovakia
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Slovenia
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South Africa
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Spain
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Sweden
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Switzerland
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Turkey
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United Kingdom
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Contacts
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Name:
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Trial Information Support Line TISL
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Address:
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Grenzacherstrasse 124
CH-4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F.Hoffmann-La Roche Ltd. |
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Name:
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Trial Information Support Line TISL
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Address:
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Grenzacherstrasse 124
CH-4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F.Hoffmann-La Roche Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Male or female patients = 16 years of age
- Histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
- Patients may or may not have received prior therapy for metastatic melanoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematologic, renal and liver function.
Are the trial subjects under 18? yes Number of subjects for this age range: 13 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 387
Exclusion criteria: - Evidence of symptomatic CNS lesions
- Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
- Concurrent administration of any anti-cancer therapies other than those administered in the study
- Known hypersensitivity to RO5185426 or another BRAF inhibitor
- Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
- Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
- Evidence of symptomatic CNS lesions as determined by investigator, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of RO5185426
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with histologically confirmed metastatic melanoma harboring the BRAF V600 mutation as determined by the cobasĀ® 4800 BRAF V600 Mutation Test. MedDRA version: 14.1
Level: LLT
Classification code 10027481
Term: Metastatic melanoma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: RO5185426 Product Code: RO5185426/F17 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: vemurafenib CAS Number: 918504-65-1 Current Sponsor code: RO5185426-006 Other descriptive name: RG7204, PLX4032 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 240-
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Primary Outcome(s)
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Main Objective: To evaluate the safety and tolerability of RO5185426 in patients with metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) harboring the BRAF V600 mutation
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Secondary Objective: To evaluate the efficacy of RO5185426 as objective response rates (ORRs) determined by the investigator (RECIST, Version 1.1)
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Timepoint(s) of evaluation of this end point: 46 months
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Primary end point(s): The primary objective of this clinical trial is to evaluate the safety and tolerability of RO5185426 in patients with metastatic melanoma (surgically incurable and unresectable stage IIIC or Stage IV, AJCC) harboring the BRAF V600 mutation (identified by the cobasĀ® 4800 BRAF V600 Mutation Test). Hence the following safety variables are primary variables: adverse events (all AEs, AEs grade 3 or 4, AEs of special interest, AEs leading to drug interruptions or discontinuations, serious adverse events (SAEs), dermatological evaluations and other assessments for SCC (chest CT scan, anal examination, cervical examination and head/neck examination), assessment for second primary malignancies, premature discontinuation from study and treatment, laboratory parameters and study medication.
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Secondary Outcome(s)
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Secondary end point(s): To evaluate the efficacy of RO5185426 as overall response rates (ORRs) determined by the investigator (RECIST, Version 1.1) as allowed by local regulatory requirements. Additional efficacy parameters will be calculated including time to tumor response, duration of response, progression free survival (PFS) and overall survival (OS)
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Timepoint(s) of evaluation of this end point: 46 months
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Secondary ID(s)
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2010-023526-21-ES
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MO25515
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NCT01307397
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Source(s) of Monetary Support
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F.Hoffmann-La Roche Ltd.
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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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