any type of solid tumor metastatic melanoma MedDRA version: 16.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.0 Level: PT Classification code 10025670 Term: Malignant melanoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.0 Level: PT Classification code 10025669 Term: Malignant mela
Conditions
Interventions
Trade Name: Zelboraf 240 mg Film-coated Tablets
Product Code: RO5185426/F17
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VEMURAFENIB
CAS Number: 918504-65-1
Current Sponsor code: RO518
Sponsors
F. Hoffman-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease-Specific Inclusion Criteria: - BRAFV600 mutation positive malignancy - Prior eligibility and treatment in an antecedent vemurafenib protocol - Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of study in the antecedent protocol General Inclusion Criteria: - Signed informed consent form(s) - Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use two adequate methods of contraception including at least one method with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: - Adverse event requiring discontinuation of vemurafenib in the antecedent protocol - Progressive disease during the antecedent protocol. If approval to treat beyond progression was already given in the antecedent protocol, the patient may roll over into the current protocol without sponsor approval. Under special circumstances, when it is felt that the patient may clinically benefit by continued therapy with vemurafenib, enrollment into this protocol and dosing beyond progression may considered, if it is judged by the investigator, in consultation with the Sponsor, to be in the best interest of the patient. All such cases will require approval of the Sponsor before enrolling the patient into this protocol. - Meeting any of the following exclusion criteria of the antecedent study at the time the patient is considered for the extension (rollover) study: - Current, recent (within 28 days prior to Day 1), or planned use of any antitumor therapy outside of this study - Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to participate in the study - History of malabsorption or other clinically significant metabolic dysfunction - History of clinically significant cardiac or pulmonary dysfunction as specified in antecedent study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide continued access to vemurafenib for eligible patients with BRAFV600 mutation-positive malignancy who were previously treated for an antecedent vemurafenib protocol without meetings its definite criteria for disease progression there and may potentially benefit from continued treatment with vemurafenib;Secondary Objective: To collect and describe ongoing/continuing safety and tolerability data for patients entering the extension (rollover), once all necessary information for the antecedent study has been collected;Primary end point(s): To provide continued access to vemurafenib for eligible patients with BRAFV600 mutation-positive malignancy who were previously treated in an antecedent vemurafenib protocol and did not meet the protocol’s criteria for disease progression, or are being treated beyond progression and are still deriving clinical benefit, as assessed by investigator and may potentially benefit from continued treatment with vemurafenib;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To collect and describe safety and tolerability data for patients who continue vemurafenib treatment in this extension (rollover) study;Timepoint(s) of evaluation of this end point: Continuous during treatment (monthly visit for the first 7 months, bi-monthly therafter) and 3 and 6 months after treatment discontinuation | — |
Countries
Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Croatia, Cyprus, Egypt, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Peru, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed