Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00111007
Registration number
NCT00111007
Ethics application status
Date submitted
16/05/2005
Date registered
17/05/2005
Date last updated
31/10/2014
Titles & IDs
Public title
A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
Query!
Scientific title
Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Paclitaxel/Carboplatin Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma.
Query!
Secondary ID [1]
0
0
2005-000941-12
Query!
Secondary ID [2]
0
0
11718
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Melanoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Malignant melanoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Sorafenib (Nexavar, BAY43-9006)
Treatment: Drugs - Carboplatin/Paclitaxel
Treatment: Drugs - Placebo
Experimental: Sorafenib (Nexavar, BAY43-9006) - Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Active Comparator: Carboplatin/Paclitaxel (C/P) - Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Treatment: Drugs: Sorafenib (Nexavar, BAY43-9006)
Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19
Treatment: Drugs: Carboplatin/Paclitaxel
Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1
Treatment: Drugs: Placebo
Placebo, 2 tablets bid Study Days 2-19
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [1]
0
0
PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.
Query!
Timepoint [1]
0
0
Time from randomization to documented tumor progression or death (median time of 124 days)
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
Overall survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.
Query!
Timepoint [1]
0
0
Time from randomization to death (median time of 294 days)
Query!
Secondary outcome [2]
0
0
Time to Progression (TTP)
Query!
Assessment method [2]
0
0
TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (DP) (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.
Query!
Timepoint [2]
0
0
Time from randomization to documented tumor progression (median time of 126 days)
Query!
Secondary outcome [3]
0
0
Duration of Response (DOR)
Query!
Assessment method [3]
0
0
Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.
Query!
Timepoint [3]
0
0
Time from initial response to documented tumor progression or death (median time of 197 days)
Query!
Secondary outcome [4]
0
0
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted
Query!
Assessment method [4]
0
0
Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).
Query!
Timepoint [4]
0
0
baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)
Query!
Eligibility
Key inclusion criteria
- Subjects who have a life expectancy of at least 12 weeks
- Subjects with histologically or cytologically confirmed unresectable (Stage III) or
metastatic (Stage IV) melanoma
- Subjects must have progressed after receiving at least one cycle of DTIC or TMZ
containing regimen
- Subjects who have an ECOG PS of 0 or 1
- Measurable disease defined as at least one lesion that can be accurately and serially
measured per the modified RECIST criteria
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Primary ocular or mucosal melanoma
- 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 [Noninvasive papillary carcinoma], Tis
[Carcinoma in situ: "flat tumor"]& T1 [Tumor invades subepithelial connective tissue])
or any cancer curatively treated < 5 years prior to study entry
- History of cardiac disease
- Known history of human immunodeficiency virus (HIV) infection
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/01/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
270
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
- Camperdown
Query!
Recruitment hospital [2]
0
0
- Warartah
Query!
Recruitment hospital [3]
0
0
- Westmead
Query!
Recruitment hospital [4]
0
0
- Brisbane
Query!
Recruitment hospital [5]
0
0
- East Melbourne
Query!
Recruitment hospital [6]
0
0
- Heidelberg
Query!
Recruitment hospital [7]
0
0
- Malvern
Query!
Recruitment hospital [8]
0
0
- Melbourne
Query!
Recruitment hospital [9]
0
0
- Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2300 - Warartah
Query!
Recruitment postcode(s) [3]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [4]
0
0
4101 - Brisbane
Query!
Recruitment postcode(s) [5]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [6]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [7]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [8]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [9]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nebraska
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New Jersey
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Ohio
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Pennsylvania
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Tennessee
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Texas
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Virginia
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Washington
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Alberta
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Ontario
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Quebec
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Bordeaux
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Boulogne-billancourt
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Brest
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Lyon Cedex
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Montpellier Cedex
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Paris
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Villejuif
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Baden-Württemberg
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Bayern
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Hessen
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Nordrhein-Westfalen
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Rheinland-Pfalz
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Saarland
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Schleswig-Holstein
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Berlin
Query!
Country [36]
0
0
Netherlands
Query!
State/province [36]
0
0
Amsterdam
Query!
Country [37]
0
0
Netherlands
Query!
State/province [37]
0
0
Rotterdam
Query!
Country [38]
0
0
Netherlands
Query!
State/province [38]
0
0
Utrecht
Query!
Country [39]
0
0
United Kingdom
Query!
State/province [39]
0
0
Hampshire
Query!
Country [40]
0
0
United Kingdom
Query!
State/province [40]
0
0
Leicestershire
Query!
Country [41]
0
0
United Kingdom
Query!
State/province [41]
0
0
Merseyside
Query!
Country [42]
0
0
United Kingdom
Query!
State/province [42]
0
0
Nottinghamshire
Query!
Country [43]
0
0
United Kingdom
Query!
State/province [43]
0
0
Surrey
Query!
Country [44]
0
0
United Kingdom
Query!
State/province [44]
0
0
West Yorkshire
Query!
Country [45]
0
0
United Kingdom
Query!
State/province [45]
0
0
London
Query!
Country [46]
0
0
United Kingdom
Query!
State/province [46]
0
0
Manchester
Query!
Country [47]
0
0
United Kingdom
Query!
State/province [47]
0
0
Swansea
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bayer
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Amgen
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The objectives of this study are to compare the anti-tumor activity as measured by
Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel
and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects
with unresectable Stage III or Stage IV melanoma who progressed after receiving only one
prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00111007
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bayer Study Director
Query!
Address
0
0
Bayer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00111007
Download to PDF