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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


Phase 2
19 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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.

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:

overall objective response

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Paul Chapman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

11-091

NCT ID:

NCT01474551

Start Date:

November 2011

Completion Date:

March 2013

Related Keywords:

  • Melanoma
  • Vemurafenib
  • skin cancer
  • Stage IV
  • advanced stage III
  • 11-091
  • Melanoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021