An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01739764
• Date of registration: 26/11/2012
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
• Scientific title: An Open-Label, Extension (Rollover) Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
• Date of first enrolment: February 19, 2013
• Target sample size: 215
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01739764
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Croatia, Cyprus, Czech Republic, Czechia, Egypt, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Sweden, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- BRAF V600 mutation-positive malignancy

- Prior eligibility for and on study treatment from an antecedent vemurafenib protocol

- Ability to begin treatment in the extension (rollover) protocol within 15 days
following the last day of the study in the antecedent protocol

- Female participants of childbearing potential and male participants with partners of
childbearing potential must agree to use 2 adequate methods of contraception as
defined by protocol during the course of this study and for at least 6 months after
completion of study treatment

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 participant may roll
over into the current protocol without sponsor approval. Under special circumstances,
enrollment into this protocol and dosing beyond progression may be considered and will
require approval of the sponsor

Participants meeting any of the following exclusion criterion of the antecedent study at
the time the participant is considered for the extension (rollover) study:

- Current, recent (within 28 days prior to Day 1), or planned use of any antitumor
therapy outside this study

- Any other serious concomitant medical condition that, in the opinion of the
investigator, would compromise the safety of the participant or compromise the
participant'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: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neoplasms

Intervention(s)

Drug: Vemurafenib

Primary Outcome(s)

Dose Intensity of Vemurafenib [Time Frame: Baseline up to a maximum of 7 years.]

Secondary Outcome(s)

Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [Time Frame: Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).]

Secondary ID(s)

2012-003144-80

GO28399

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/11/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01739764