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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:	EUCTR
Last refreshed on:	28 November 2016
Main ID:	EUCTR2010-023526-21-NL
Date of registration:	11/01/2011
Prospective Registration:	Yes
Primary sponsor:	F. Hoffmann-La Roche Ltd.
Public title:	An open-label, multicenter expanded access study of RO5185426 in patients with metastatic melanoma
Scientific title:	An open-label, multicenter expanded access study of RO5185426 in patients with metastatic melanoma
Date of first enrolment:	10/03/2011
Target sample size:	900
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023526-21
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Austria	Belgium	Bulgaria	Czech Republic	Denmark	Estonia	Finland	Germany
Greece	Hungary	Ireland	Italy	Latvia	Lithuania	Netherlands	Norway
Portugal	Slovakia	Slovenia	Spain	Sweden	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
- Adult patients, >/= 18 years of age
- Histologically confirmed metastatic melanoma with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
- Disease Progression after at least one prior systemic treatment for metastatic melanoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematologic, renal and liver function"

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
- 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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Adult patients with histologically confirmed metastatic melanoma harboring the BRAF V600 mutation as determined by the cobas® 4800 BRAF V600 Mutation Test. Patients must have failed at least one previous systemic treatment for melanoma.
MedDRA version: 12.1 Level: LLT Classification code 10027481 Term: Metastatic melanoma

Intervention(s)

Product Name: RO5185426
Product Code: RO5185426/F17
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO5185426-006
Other descriptive name: PLX4032
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-

Primary Outcome(s)

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 (Stage IV, AJCC) harboring the BRAF V600 mutation (identified by the cobas® 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, premature discontinuation from study and treatment, laboratory parameters and study medication.

Secondary Objective: To evaluate the efficacy of RO5185426 as objective response rates (ORRs) determined by the investigator (RECIST, Version 1.1) as allowed by local regulatory requirements

Main Objective: To evaluate the safety and tolerability of RO5185426 in patients with metastatic melanoma (Stage IV; AJCC) harboring the BRAF V600 mutation

Secondary Outcome(s)

Secondary ID(s)

2010-023526-21-ES

MO25515

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
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