Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00300885




Registration number
NCT00300885
Ethics application status
Date submitted
8/03/2006
Date registered
10/03/2006
Date last updated
4/11/2014

Titles & IDs
Public title
A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2005-005245-19
Secondary ID [2] 0 0
11961
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel
Treatment: Drugs - Carboplatin plus Paclitaxel

Experimental: Sorafenib + C/P - Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.

Active Comparator: Placebo + C/P - Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.


Treatment: Drugs: Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel
Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.

Treatment: Drugs: Carboplatin plus Paclitaxel
Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo
Timepoint [1] 0 0
Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis
Secondary outcome [2] 0 0
Overall Best Response
Timepoint [2] 0 0
Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis
Secondary outcome [4] 0 0
Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)
Timepoint [4] 0 0
Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis
Secondary outcome [5] 0 0
Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)
Timepoint [5] 0 0
Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis

Eligibility
Key inclusion criteria
- Stage IIIB (with effusion) or Stage IV NSCLC any histology

- No prior chemotherapy

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Greater than or equal to 18 years of age

- Life expectancy at least 12 weeks

- Adequate bone marrow, liver and renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior systemic anti cancer therapy

- Known brain metastasis. Patients with neurological symptoms should undergo at computed
tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain
metastasis

- Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events
(CTCAE) Grade 2 within 4 weeks of first dose of study drug

- Thrombotic or embolic events including Transient ischemic attack (TIA) within the past
6 months

- Uncontrolled hypertension

- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of
study drug

- Major surgery within 4 weeks

- Evidence or history of bleeding diathesis or coagulopathy

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
926
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Port Macquarie
Recruitment hospital [2] 0 0
- Wollongong
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Adelaide
Recruitment hospital [5] 0 0
- Frankston
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5065 - Adelaide
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3144 - Melbourne
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel
plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00300885
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00300885