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

Primary Purpose

Melanoma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

vemurafenib

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Vemurafenib, skin cancer, Stage IV, advanced stage III, 11-091

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vemurafenib

Arm Description

This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01474551

First Posted

November 15, 2011

Last Updated

October 20, 2015

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01474551

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

Lack of accrual

Study Start Date

November 2011 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Genentech, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Vemurafenib, skin cancer, Stage IV, advanced stage III, 11-091

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vemurafenib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

vemurafenib

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Objective Response

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Chapman, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22431777

Citation

Alloo A, Garibyan L, LeBoeuf N, Lin G, Werchniak A, Hodi FS Jr, Flaherty KT, Lawrence DP, Lin JY. Photodynamic therapy for multiple eruptive keratoacanthomas associated with vemurafenib treatment for metastatic melanoma. Arch Dermatol. 2012 Mar;148(3):363-6. doi: 10.1001/archdermatol.2011.3080.

Results Reference

derived

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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