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An Open-Label, Multicenter, Phase II Study Of Continuous Oral Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

Thank you

Trial Information

An Open-Label, Multicenter, Phase II Study Of Continuous Oral Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E


Inclusion Criteria:



- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 2

- Histologically-confirmed metastatic melanoma (unresectable Stage IIIc or IV) with an
activating BRAF mutation other than V600E

- Measurable disease (as defined by RECIST, v1.1)

- Adequate recovery from most recent systemic or local treatment for cancer

- Adequate organ function

- Women of childbearing potential and male partners of women of childbearing potential:
agreement to use prescribed contraception.

- Negative serum pregnancy test within 7 days of commencement of treatment in
premenopausal women. Women who are either surgically sterile or have been
post-menopausal for at least 1 year are eligible to participate in this study

- Agreement not to donate blood or blood products during the study and for at least 6
months after discontinuation of vemurafenib; for male patients, agreement not to
donate sperm during the study and for at least 6 months after discontinuation of
vemurafenib

Exclusion Criteria:

- Invasive malignancy other than melanoma at the time of enrollment and within 2 years
prior

- Pregnant or breast-feeding

- Concurrent anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation
therapy, including participation in an experimental drug study)

- Either a concurrent condition or history of a prior condition that places the patient
at unacceptable risk if he/she were treated with the study drug or confounds the
ability to interpret data from the study

- Ongoing cardiac dysrhythmia >/= Grade 2

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best objective response rate (BORR) according to RECIST, v1.1 guidelines

Outcome Time Frame:

approximately 18 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

ML27763

NCT ID:

NCT01586195

Start Date:

October 2011

Completion Date:

September 2016

Related Keywords:

  • Malignant Melanoma
  • Melanoma

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Denver, Colorado