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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00111007




Trial ID
NCT00111007
Ethics application status
Date submitted
16/05/2005
Date registered
16/05/2005
Date last updated
23/10/2014

Titles & IDs
Public title
A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
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.
Secondary ID [1] 0 0
2005-000941-12
Secondary ID [2] 0 0
11718
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) - 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.
Timepoint [1] 0 0
Time from randomization to documented tumor progression or death (median time of 124 days)
Secondary outcome [1] 0 0
Overall Survival (OS) - 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.
Timepoint [1] 0 0
Time from randomization to death (median time of 294 days)
Secondary outcome [2] 0 0
Time to Progression (TTP) - 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.
Timepoint [2] 0 0
Time from randomization to documented tumor progression (median time of 126 days)
Secondary outcome [3] 0 0
Duration of Response (DOR) - 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.
Timepoint [3] 0 0
Time from initial response to documented tumor progression or death (median time of 197 days)
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 - 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).
Timepoint [4] 0 0
baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Warartah
Recruitment hospital [3] 0 0
- Westmead
Recruitment hospital [4] 0 0
- Brisbane
Recruitment hospital [5] 0 0
- East Melbourne
Recruitment hospital [6] 0 0
- Heidelberg
Recruitment hospital [7] 0 0
- Malvern
Recruitment hospital [8] 0 0
- Melbourne
Recruitment hospital [9] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2300 - Warartah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
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State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
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Illinois
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United States of America
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Kentucky
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Missouri
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Nebraska
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United States of America
State/province [10] 0 0
New Jersey
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United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux
Country [22] 0 0
France
State/province [22] 0 0
Boulogne-billancourt
Country [23] 0 0
France
State/province [23] 0 0
Brest
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France
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Lyon Cedex
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France
State/province [25] 0 0
Montpellier Cedex
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France
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Paris
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France
State/province [27] 0 0
Villejuif
Country [28] 0 0
Germany
State/province [28] 0 0
Baden-W├╝rttemberg
Country [29] 0 0
Germany
State/province [29] 0 0
Bayern
Country [30] 0 0
Germany
State/province [30] 0 0
Hessen
Country [31] 0 0
Germany
State/province [31] 0 0
Nordrhein-Westfalen
Country [32] 0 0
Germany
State/province [32] 0 0
Rheinland-Pfalz
Country [33] 0 0
Germany
State/province [33] 0 0
Saarland
Country [34] 0 0
Germany
State/province [34] 0 0
Schleswig-Holstein
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Netherlands
State/province [36] 0 0
Amsterdam
Country [37] 0 0
Netherlands
State/province [37] 0 0
Rotterdam
Country [38] 0 0
Netherlands
State/province [38] 0 0
Utrecht
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United Kingdom
State/province [39] 0 0
Hampshire
Country [40] 0 0
United Kingdom
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Leicestershire
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United Kingdom
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Merseyside
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United Kingdom
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Nottinghamshire
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United Kingdom
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Surrey
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United Kingdom
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West Yorkshire
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
State/province [47] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Amgen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT00111007
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries