check_circleStudy Completed

Melanoma

Bayer Identifier:

11538

ClinicalTrials.gov Identifier:

NCT00492297

EudraCT Number:

2004-000725-30

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
April 2005 - July 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Royal Marsden Hospital (London)London, SW3 6JJ, United Kingdom
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
Royal Free HospitalLondon, NW3 2QG, United Kingdom
Completed
Southampton General HospitalSouthampton, SO16 6YD, United Kingdom
Completed
St Thomas' HospitalLondon, SE1 7EH, United Kingdom
Completed
Institut Gustave Roussy - VillejuifVILLEJUIF, 94805, France
Completed
Institut Claudius Regaud - ToulouseTOULOUSE, 31052, France
Completed
Addenbrookes HospitalCambridge, CB2 0QQ, United Kingdom
Completed
Mount Vernon HospitalNorthwood, HA6 2RN, United Kingdom
Completed
Christie HospitalManchester, M20 4BX, United Kingdom
Completed
Centre Léon BérardLYON CEDEX, 39373, France
Completed
Hôpital Saint André - BordeauxBORDEAUX, 33000, France

Primary Outcome

  • Overall Best Response
    date_rangeTime Frame:
    during or within 30 days after active therapy
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    Safety Issue:
    No

Secondary Outcome

  • Progression-free Survival
    date_rangeTime Frame:
    from start of treatment until progression or death before progression (median 259 days)
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    Safety Issue:
    No
  • Percentage of Subjects With Progression-free Survival at Specific Time-points
    date_rangeTime Frame:
    from start of treatment until progression or death before progression after 3, 6 and 12 months
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    Safety Issue:
    No
  • Overall Survival
    date_rangeTime Frame:
    from start of treatment until death (median 259 days)
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    Safety Issue:
    No
  • Duration of Response
    date_rangeTime Frame:
    from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)
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    Safety Issue:
    No
  • Duration of Complete Response
    date_rangeTime Frame:
    from confirmed CR until PD (median 259 days)
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    Safety Issue:
    No
  • Duration of Partial Response
    date_rangeTime Frame:
    from confirmed PR until PD (median 259 days)
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    Safety Issue:
    No
  • Disease Control (DC)
    date_rangeTime Frame:
    after start of treatment, at 6 months and 12 months
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    Safety Issue:
    No
  • Duration of Stable Disease
    date_rangeTime Frame:
    from start of therapy to PD, only in non-responders (median 259 days)
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    Safety Issue:
    No
  • Time to Response
    date_rangeTime Frame:
    start of therapy to confirmed CR or PR (median 259 days)
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    Safety Issue:
    No
  • Time to Progression
    date_rangeTime Frame:
    From start of treatment until progression (median 259 days)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

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