Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation

Melanoma Clinical Trial

Official title:

A Single Center Phase II Trial of Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01474551
• Other study ID #: 11-091
• Status: Terminated
• Phase: Phase 2
• First received: November 15, 2011
• Last updated: October 20, 2015
• Start date: November 2011
• Est. completion date: March 2013

Study information

• Verified date: October 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out what effects, good and/or bad, vemurafenib has on the patient and the melanoma. Specifically, the investigators want to know how well vemurafenib shrinks melanoma. The investigators also want to find out how well vemurafenib can improve how well the patient functions.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years old.

• Histologic proof of melanoma reviewed and confirmed by MSKCC.

• A confirmed EBRAFV600E or KBRAFV600K mutation.

• Stage IV melanoma, or advanced stage III not curable by surgery. Patients with active CNS metastases will be allowed on the study.

• Measurable disease by RECIST v1.1.

• ECOG performance status 3 or 4. The basis for the grading of performance is strict; there must be clear justification of the performance status grade (e.g. patient is confined to bed > 50% of time, or cannot carry out ADLs, or is otherwise disabled by burden of disease such as requiring supplemental O2).

• Patients must be able to swallow pills

• Adequate hematologic, hepatic and renal function as defined by the following:

• Absolute Neutrophil Count = 1.0 x 109/L

• Hemoglobin =8.0g/dL, occasional transfusions are acceptable as vemurafenib does not have significant hematologic toxicities.

• Total bilirubin =2.0x the upper limit of normal, =3.0x the upper limit of normal if the patient has Gilbert's Syndrome.

• Alkaline phosphatase =2.0x the upper limit of normal.

• AST and ALT =2.0x the upper limit of normal.

• Serum creatinine = 1.5x the upper limit of normal.

Exclusion Criteria:

• Uveal melanoma as primary.

• Concurrent chemotherapy, immunotherapy, or radiotherapy.

• Prior treatment with a RAF inhibitor. Other prior chemotherapy, immunotherapy, or radiotherapy will be allowed including prior treatment with a MEK inhibitor Patients must have had complete recovery from any adverse events or toxicities of prior cancer-directed therapies.

• Pregnant or lactating women.

• A second active malignancy. Prior malignancy will be allowed as long as the patient is known to be free of disease for at least 2 years. Patients with indolent B-cell malignancies will not be eligible.

• QTc interval > 500 msec.

Study Design

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• vemurafenib
All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Objective Response	The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response. In order to be considered evaluable for response, a patient must have completed at least 1 cycle of therapy. Patients who do not complete a cycle of therapy can be replaced.	2 years	No

External Links

•   Memorial Sloan Kettering Cancer Center