NCT00119249

Brief Summary

Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

2.4 years

First QC Date

July 12, 2005

Last Update Submit

January 14, 2013

Conditions

Stage III MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Response rate (RR) defined as is either a complete or a partial response using RECIST criteria

    The overall response rate along with subgroup-specific response rates will be estimated at the end of the trial along with 95% confidence interval.

    56 days

Secondary Outcomes (4)

  • Time to progression

    From the first day of treatment until the first documentation of disease progression, assessed up to 3.5 years

  • Toxicity assessed using NCI CTCAE version 3.0

    Up to 3.5 years

  • Changes in BRAF, P-MAPK, CDK4, and cyclin D1 levels

    Baseline and up to 3.5 years

  • Overall survival

    Up to 3.5 years

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: sorafenib tosylateOther: laboratory biomarker analysis

Interventions

sorafenib tosylateDRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Treatment (sorafenib tosylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (sorafenib tosylate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed unresectable melanoma
  • Stage III or IV disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques OR \> 10 mm by spiral CT scan
  • Disease amenable to biopsy (first 13 patients in each stratum only)
  • Brain metastases allowed provided the following criteria are met:
  • Disease has remained radiologically stable for ≥ 6 weeks after completion of whole-brain radiotherapy and remains stable at the time of study entry
  • No mass effect present by radiology
  • No requirement for steroid therapy to control symptoms of brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • At least 3 months
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • No evidence of bleeding diathesis
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

Related Publications (1)

  • Ott PA, Hamilton A, Min C, Safarzadeh-Amiri S, Goldberg L, Yoon J, Yee H, Buckley M, Christos PJ, Wright JJ, Polsky D, Osman I, Liebes L, Pavlick AC. A phase II trial of sorafenib in metastatic melanoma with tissue correlates. PLoS One. 2010 Dec 29;5(12):e15588. doi: 10.1371/journal.pone.0015588.

    PMID: 21206909DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Anna Pavlick

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 13, 2005

Study Start

June 1, 2005

Primary Completion

November 1, 2007

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

US(1)