Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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
This study has been completed.
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00492297
  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 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.


Condition Intervention Phase
Cancer
Melanoma
Drug: Nexavar (Sorafenib, BAY43-9006)
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Dacarbazine Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II, Multi-Center, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma.

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Evaluate overall tumour response rate including CR and PR using RECIST criteria [ Time Frame: 31 Mar 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 31 Mar 2008 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 31 Mar 2008 ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 31 Mar 2008 ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: 31 Mar 2008 ] [ Designated as safety issue: No ]
  • Duration of Stable Disease [ Time Frame: 31 Mar 2008 ] [ Designated as safety issue: No ]
  • Time to Response [ Time Frame: 31 Mar 2008 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 31 Mar 2008 ] [ Designated as safety issue: Yes ]
  • Braf Mutations in patients with melanoma [ Time Frame: 31 Mar 2008 ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: April 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental Drug: Nexavar (Sorafenib, BAY43-9006)
Multi Kinase Inhibitor: Dacarbazine 1000mg/m2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib, 400mg bid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 CT or MRI scan as per the 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 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492297

Locations
France
VILLEJUIF CEDEX, France, 94305
LYON CEDEX, France, 69008
BORDEAUX, France, 33000
TOULOUSE, France, 31052
United Kingdom, Cambridgeshire
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
United Kingdom, Greater London
London, Greater London, United Kingdom, SW3 6JJ
London, Greater London, United Kingdom, NW3 2QG
London, Greater London, United Kingdom, SE1 7EH
United Kingdom, Greater Manchester
Manchester, Greater Manchester, United Kingdom, M20 4BX
United Kingdom, Hampshire
Southampton, Hampshire, United Kingdom, SO16 6YD
United Kingdom, Middlesex
Northwood, Middlesex, United Kingdom, HA6 2RN
United Kingdom, Surrey
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to marketed products  This link exits the ClinicalTrials.gov site

Responsible Party: Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers: 11538, EudraCT 2004-000725-30
Study First Received: June 26, 2007
Last Updated: October 16, 2008
ClinicalTrials.gov Identifier: NCT00492297  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency;   France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Neuroectodermal Tumors
Dacarbazine
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Sorafenib
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Protein Kinase Inhibitors
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009