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

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ClinicalTrials.gov Identifier: NCT01474551
Recruitment Status : Terminated (Lack of accrual)
First Posted : November 18, 2011
Results First Posted : April 30, 2015
Last Update Posted : November 18, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE November 15, 2011
First Posted Date  ICMJE November 18, 2011
Results First Submitted Date  ICMJE April 15, 2015
Results First Posted Date  ICMJE April 30, 2015
Last Update Posted Date November 18, 2015
Study Start Date  ICMJE November 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2011)
Overall Objective Response [ Time Frame: 2 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01474551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2011)
  • effects of clinical benefit [ Time Frame: 2 years ]
    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 ]
    Time to progression and overall survival will be estimated using Kaplan-Meier methodology.
  • To assess toxicity [ Time Frame: 2 years ]
    All adverse events encountered during the study will be evaluated according to the NCI Common Toxicity Grading system version 4.0.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 14, 2013)
2
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2011)
22
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01474551
Other Study ID Numbers  ICMJE 11-091
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Paul Chapman, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date October 2015

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