Vemurafenib Extension (Rollover) study to provide continued access to vemurafenib for eligible patients who were previously treated in an antecedent vemurafenib protocol

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2012-003144-80-ES
• Date of registration: 09/04/2013
• Prospective Registration: Yes
• Primary sponsor: F. Hoffman-La Roche Ltd.
• Public title: Vemurafenib Extension (Rollover) study to provide continued access to vemurafenib for eligible patients who were previously treated in an antecedent vemurafenib protocol
• Scientific title: A PHASE IV, POSTMARKETING, OPEN-LABEL, EXTENSION (ROLLOVER) STUDY OF VEMURAFENIB IN PATIENTS WITH BRAFV600 MUTATION?POSITIVE MALIGNANCIES PREVIOUSLY ENROLLED IN AN ANTECEDENT VEMURAFENIB PROTOCOL
• Date of first enrolment: 21/06/2013
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003144-80
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; 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): no Therapeutic use (Phase IV): yes

Countries of recruitment

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

• 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:
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 < 1% per year during the course of this study and for at least 6 months after completion of study treatment.
- Females of childbearing potential are defined as sexually mature women without prior hysterectomy who have had any evidence of menses in the past 12 months. In order to be considered NOT of childbearing potential, amenorrhea for a period of 12 months or longer must have occurred in the absence of chemotherapy, anti estrogen therapy, or ovarian suppression.
- Effective forms of contraception include surgical sterilization, a reliable barrier method with spermicide, birth control pills, contraceptive hormone implants, or vasectomized partner.
- Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential; women of non-childbearing potential may be included if they are either surgically sterile or have been naturally menopausal for ? 1 year. Women of non childbearing potential need not undergo the pregnancy test.
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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


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

Health Condition(s) or Problem(s) studied

any type of solid tumor metastatic melanoma
MedDRA version: 14.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1 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: 14.1 Level: PT Classification code 10025669 Term: Malignant melanoma stage II 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 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, Zelboraf
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-

Primary Outcome(s)

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

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

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

Timepoint(s) of evaluation of this end point: NA

Secondary Outcome(s)

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

Secondary ID(s)

2012-003144-80-GB

GO28399

Source(s) of Monetary Support

F.Hoffmann-La Roche Ltd.

Ethics review

Status: Approved
Approval date:
Contact: