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

Status:	Active, not recruiting
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/8/2019
Start Date:	February 19, 2013
End Date:	June 24, 2020

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

This open-label, multicenter, non-randomized study will provide continued access to
vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were
previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the
protocol's criteria for disease progression, or are treated beyond progression and are still
deriving clinical benefit (as assessed by investigator), and may therefore potentially
benefit from continued treatment with vemurafenib. Participants will receive treatment with
oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID,
depending on the last dose in the antecedent protocol. Treatment will continue until
progression of disease or as long as the participant is deriving clinical benefit, as judged
by the investigator (case-by-case decision with approval of the Medical Monitor), death,
withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor
to terminate the study, whichever occurs first.

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

We found this trial at

sites

New York University Medical Center PRIME

New York, New York 10016

from

New York, NY