check_circleStudy Completed
Melanoma
Bayer Identifier:
11538
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
18 YearsTrial summary
Enrollment Goal
83Trial Dates
April 2005 - July 2008Phase
Phase 2Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Royal Marsden Hospital (London) | London, SW3 6JJ, United Kingdom |
Completed | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Completed | Royal Free Hospital | London, NW3 2QG, United Kingdom |
Completed | Southampton General Hospital | Southampton, SO16 6YD, United Kingdom |
Completed | St Thomas' Hospital | London, SE1 7EH, United Kingdom |
Completed | Institut Gustave Roussy - Villejuif | VILLEJUIF, 94805, France |
Completed | Institut Claudius Regaud - Toulouse | TOULOUSE, 31052, France |
Completed | Addenbrookes Hospital | Cambridge, CB2 0QQ, United Kingdom |
Completed | Mount Vernon Hospital | Northwood, HA6 2RN, United Kingdom |
Completed | Christie Hospital | Manchester, M20 4BX, United Kingdom |
Completed | Centre Léon Bérard | LYON CEDEX, 39373, France |
Completed | Hôpital Saint André - Bordeaux | BORDEAUX, 33000, France |
Primary Outcome
- Overall Best Responsedate_rangeTime Frame:during or within 30 days after active therapyenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Progression-free Survivaldate_rangeTime Frame:from start of treatment until progression or death before progression (median 259 days)enhanced_encryptionNoSafety Issue:
- Percentage of Subjects With Progression-free Survival at Specific Time-pointsdate_rangeTime Frame:from start of treatment until progression or death before progression after 3, 6 and 12 monthsenhanced_encryptionNoSafety Issue:
- Overall Survivaldate_rangeTime Frame:from start of treatment until death (median 259 days)enhanced_encryptionNoSafety Issue:
- Duration of Responsedate_rangeTime Frame:from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)enhanced_encryptionNoSafety Issue:
- Duration of Complete Responsedate_rangeTime Frame:from confirmed CR until PD (median 259 days)enhanced_encryptionNoSafety Issue:
- Duration of Partial Responsedate_rangeTime Frame:from confirmed PR until PD (median 259 days)enhanced_encryptionNoSafety Issue:
- Disease Control (DC)date_rangeTime Frame:after start of treatment, at 6 months and 12 monthsenhanced_encryptionNoSafety Issue:
- Duration of Stable Diseasedate_rangeTime Frame:from start of therapy to PD, only in non-responders (median 259 days)enhanced_encryptionNoSafety Issue:
- Time to Responsedate_rangeTime Frame:start of therapy to confirmed CR or PR (median 259 days)enhanced_encryptionNoSafety Issue:
- Time to Progressiondate_rangeTime Frame:From start of treatment until progression (median 259 days)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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