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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01586195
Other study ID # ML27763
Secondary ID
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


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
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