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
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.
2 other identifiers
interventional
83
2 countries
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2005
Typical duration for phase_2
12 active sites
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
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
January 25, 2011
CompletedOctober 31, 2014
October 1, 2014
3.2 years
June 26, 2007
October 28, 2009
October 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Best Response
Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions.
during or within 30 days after active therapy
Secondary Outcomes (10)
Progression-free Survival
from start of treatment until progression or death before progression (median 259 days)
Percentage of Subjects With Progression-free Survival at Specific Time-points
from start of treatment until progression or death before progression after 3, 6 and 12 months
Overall Survival
from start of treatment until death (median 259 days)
Duration of Response
from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)
Duration of Complete Response
from confirmed CR until PD (median 259 days)
- +5 more secondary outcomes
Study Arms (1)
Sorafenib + Dacarbazine
EXPERIMENTALDacarbazine 1000 mg/m\^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)
Interventions
Dacarbazine 1000 mg/m\^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (12)
Unknown Facility
Bordeaux, 33000, France
Unknown Facility
Lyon, 39373, France
Unknown Facility
Toulouse, 31052, France
Unknown Facility
Villejuif, 94805, France
Unknown Facility
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Unknown Facility
Southampton, Hampshire, SO16 6YD, United Kingdom
Unknown Facility
London, London, NW3 2QG, United Kingdom
Unknown Facility
London, London, SE1 7EH, United Kingdom
Unknown Facility
London, London, SW3 6JJ, United Kingdom
Unknown Facility
Manchester, Manchester, M20 4BX, United Kingdom
Unknown Facility
Northwood, Middlesex, HA6 2RN, United Kingdom
Unknown Facility
Sutton, Surrey, SM2 5PT, United Kingdom
Related Publications (1)
Eisen T, Marais R, Affolter A, Lorigan P, Robert C, Corrie P, Ottensmeier C, Chevreau C, Chao D, Nathan PD, Jouary T, Harries M, Negrier S, Montegriffo E, Ahmad T, Gibbens I, James MG, Strauss UP, Prendergast S, Gore ME. Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies. Br J Cancer. 2011 Jul 26;105(3):353-9. doi: 10.1038/bjc.2011.257. Epub 2011 Jul 12.
PMID: 21750549RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the small number of patients, no conclusions can be drawn from these data in terms of BRAF mutations.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 27, 2007
Study Start
April 1, 2005
Primary Completion
June 1, 2008
Study Completion
July 1, 2008
Last Updated
October 31, 2014
Results First Posted
January 25, 2011
Record last verified: 2014-10