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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

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


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- 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 patients of childbearing potential and male patients with partners of
childbearing potential must agree to use two 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 patient 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.

Patients meeting any of the following exclusion criterion 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 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patients with BRAF V600 mutation-positive malignancy from earlier vemurafenib protocols meeting criteria for continuation of vemurafenib treatment

Outcome Time Frame:

up to approximately 5.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

GO28399

NCT ID:

NCT01739764

Start Date:

February 2013

Completion Date:

January 2014

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Bettendorf, Iowa  52722
Fountain Valley, California  92708
Columbia, Missouri  65203
Cleveland, Ohio  44195
Austin, Texas  78705
Flint, Michigan  48532
Louisville, Kentucky  40207
Little Rock, Arkansas  72205-7199
Charlotte, North Carolina  
Charleston, West Virginia  25304