Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01586195
• Other study ID #: ML27763
• Status: Terminated
• Phase: Phase 2
• First received: April 24, 2012
• Last updated: May 4, 2016
• Start date: October 2011
• Est. completion date: April 2015

Study information

• Verified date: May 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, single-agent, 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• Zelboraf (vemurafenib)
repeating oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best objective response rate (BORR) according to RECIST, v1.1 guidelines		approximately 18 months	No
Secondary	Time to response according to RECIST, v1.1 guidelines		approximately 18 months	No
Secondary	Duration of response according to RECIST, v1.1 guidelines		approximately 18 months	No
Secondary	Progression-free survival (PFS) according to RECIST, v1.1 guidelines		approximately 18 months	No
Secondary	Overall survival according to RECIST, v1.1 guidelines		approximately 18 months	No
Secondary	Safety: Incidence of adverse events		approximately 18 months	No