Trial Condition(s):

Melanoma

A Phase II, Multi-Center, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Sorafenib Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma

Bayer Identifier:

11538

ClinicalTrials.gov Identifier:

NCT00492297

EudraCT Number:

2004-000725-30

Study Completed

Trial Purpose

The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.

Inclusion Criteria
- Subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable 
- Age >= 18 years 
- Subject has measurable and evaluable disease defined as at least one metastatic lesion that can be accurately and serially measured by 	Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan as per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Cutaneous lesions measuring at least 20mm in longest diameter can be considered measurable (and therefore target lesions) via color photography including a ruler
- Subject has biopsiable disease at baseline and is willing to provide biopsy samples, or does not have biopsiable disease at baseline 
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria
- Primary ocular or mucosal melanoma (cutaneous vulval melanoma is permitted) 
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry 
- (Active coronary artery disease or ischemia (myocardial infarction more than 6 months prior to study entry is allowed) 
- Uncontrolled hypertension (> grade 2 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0) 
- Active, clinically serious infections (> grade 2 NCI-CTCAE version 3.0) 
- Subjects with seizure disorder requiring medication are excluded 
- History of or suspected Human Immunodeficiency Virus (HIV) infection, or chronic hepatitis B or C 
- Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry.  Also the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies) 
- Pregnant or breast-feeding subjects

Trial Summary

Enrollment Goal
83
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Royal Marsden Hospital (London)

London, United Kingdom, SW3 6JJ

Status
Completed
 
Locations

Royal Marsden NHS Trust (Surrey)

Sutton, United Kingdom, SM2 5PT

Status
Completed
 
Locations

Royal Free Hospital

London, United Kingdom, NW3 2QG

Status
Completed
 
Locations

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
Locations

St Thomas' Hospital

London, United Kingdom, SE1 7EH

Status
Completed
 
Locations

Institut Gustave Roussy - Villejuif

VILLEJUIF, France, 94805

Status
Completed
 
Locations

Institut Claudius Regaud - Toulouse

TOULOUSE, France, 31052

Status
Completed
 
Locations

Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Status
Completed
 
Locations

Mount Vernon Hospital

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

Christie Hospital

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Centre Léon Bérard

LYON CEDEX, France, 39373

Status
Completed
 
Locations

Hôpital Saint André - Bordeaux

BORDEAUX, France, 33000

Status
Completed
 

Trial Design