An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanoma

• Register: EUCTR
• Last refreshed on: 24 July 2017
• Main ID: EUCTR2010-023526-21-SE
• Date of registration: 23/12/2010
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd.
• Public title: An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanoma
• Scientific title: An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanoma
• Date of first enrolment: 02/02/2011
• Target sample size: 3300
• 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: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Albania, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom

Contacts

• Name: Trial Information Support Line TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

• Name: Trial Information Support Line TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

Key inclusion & exclusion criteria

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: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2381
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 914

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

Health Condition(s) or Problem(s) studied

Patients with histologically confirmed metastatic melanoma harboring the BRAF V600 mutation as determined by the cobas® 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)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Zelboraf 240 mg Film-coated Tablets
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-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 46 months

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 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 (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.

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

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 46 months

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)

Secondary ID(s)

2010-023526-21-ES

MO25515

NCT01307397

Source(s) of Monetary Support

F.Hoffmann-La Roche Ltd.