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

This study has been terminated.
(Lack of accrual)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01474551
First received: November 15, 2011
Last updated: March 14, 2013
Last verified: March 2013

November 15, 2011
March 14, 2013
November 2011
March 2013   (final data collection date for primary outcome measure)
overall objective response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01474551 on ClinicalTrials.gov Archive Site
  • effects of clinical benefit [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    i.e. improvement in performance and functional status). The effects on clinical benefit (changes in ECOG performance status, timed "up and go", Katz score of ADLs, and achievement of personal aspiration) will be reported but no formal statistical analysis is planned.
  • Time to progression and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time to progression and overall survival will be estimated using Kaplan-Meier methodology.
  • To assess toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    All adverse events encountered during the study will be evaluated according to the NCI Common Toxicity Grading system version 4.0.
Same as current
Not Provided
Not Provided
 
Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
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.
Experimental: vemurafenib
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.
Intervention: Drug: vemurafenib
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01474551
11-091
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Genentech, Inc.
Principal Investigator: Paul Chapman, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP