Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000316505
Ethics application status
Approved
Date submitted
12/07/2006
Date registered
24/07/2006
Date last updated
8/02/2021
Date data sharing statement initially provided
8/02/2021
Date results provided
8/02/2021
Type of registration
Prospectively registered

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)
Bay 43-9006 / 11961
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] 284 0
ClinicalTrials.gov: NCT00300885
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 1287 0
Condition category
Condition code
Cancer 1377 1377 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized, double blind, placebo controlled, multicenter, Phase III study designed to compare the efficacy of sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for patients with NSCLC Stage IV or Stage IIIB with pleural or pericardial effusion.
The study population will include chemonaive patients with unresectable Stage IIIB (with pleural or pericardial effusion) or Stage IV NSCLC for whom treatment with paclitaxel and carboplatin is considered medically acceptable.
Patients will be randomized in a double-blind fashion using a 1:1 allocation of patients to sorafenib in combination with paclitaxel and carboplatin (sorafenib group) or placebo in combination with paclitaxel and carboplatin (placebo group).
Patients will receive up to 6 cycles (21 day cycles) of paclitaxel (200 mg/m2 IV on Day 1, based on body weight) and carboplatin (AUC 6 IV on Day 1, based on body weight) in combination with either sorafenib (800 mg orally twice daily) or placebo.
Intervention code [1] 1200 0
Treatment: Drugs
Comparator / control treatment
Placebo in combination with paclitaxel and carboplatin (placebo group)
Control group
Placebo

Outcomes
Primary outcome [1] 1878 0
The primary efficacy objective is to compare overall survival (OS) in patients treated with carboplatin, paclitaxel and sorafenib to OS in patients treated with carboplatin, paclitaxel and placebo.
Timepoint [1] 1878 0
The outcome is measured after up to 6 cylces (21 day cycles) of treatment.
Secondary outcome [1] 3321 0
Secondary objectives include tumor response, duration of response, progression free survival and patient reported outcomes.
Timepoint [1] 3321 0
The secondary outcomes are measured after up to 6 cylces (21 day cycles) of treatment.

Eligibility
Key inclusion criteria
Stage IIIB (with cytologically confirmed malignant pleural or pericardial effusion) or Stage IV histological or cytological confirmation of NSCLC.No prior chemotherapy.Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug.Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study drug. Performance status (Eastern Cooperative Group) of 0 or 1. Life expectancy of at least 12 weeks.Adequate bone marrow, liver and renal function.Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC.Cardiac disease: Congestive heart failure > class II New York Heart Association. Patients must not have unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Known brain metastasis. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Uncontrolled hypertension. Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. Active clinically serious infections. Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months. Pulmonary hemorrhage/bleeding event within 4 weeks of first dose of study drug. Any other hemorrhage/bleeding event within 4 weeks of first dose of study drug.Serious, non-healing wound, ulcer, or bone fracture.Evidence or history of bleeding diathesis or coagulopathy.Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.Therapeutic anticoagulation with vitamin K antagonists.Use of St John’s Wort or rifampin (rifampicin).Known or suspected allergy to sorafenib or any agent given in the course of this trial. Previous cancer that is distinct in primary site or histology from NSCLC, EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated less than 3 years prior to study entry.Concurrent cancer that is distinct in primary site or histology from NSCLC.Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.Any condition that impairs patient’s ability to swallow whole pills. Any malabsorption condition.

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)
The packaging and dosage will be such, that the sorafenib group will appear identical to the placebo group. an interactive voice response system will be used to accomplish a blind allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation list will be generated by Bayer. Randomisation will be performed by telephone using an interactive voice reconition system (IVRS).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Based on the results of the interim analysis it was determined that the study would not meet its primary efficacy endpoint and the study was terminated early.
Date of first participant enrolment
Anticipated
13/02/2006
Actual
25/08/2006
Date of last participant enrolment
Anticipated
Actual
27/04/2007
Date of last data collection
Anticipated
9/02/2009
Actual
9/02/2009
Sample size
Target
926
Accrual to date
Final
926
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 1509 0
Commercial sector/Industry
Name [1] 1509 0
Bayer Australia Ltd
Country [1] 1509 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bayer Australia Limited
Address
875 Pacific Highway Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 1326 0
None
Name [1] 1326 0
Nil
Address [1] 1326 0
Country [1] 1326 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2930 0
Port Macquarie Base Hospital
Ethics committee address [1] 2930 0
Ethics committee country [1] 2930 0
Australia
Date submitted for ethics approval [1] 2930 0
Approval date [1] 2930 0
13/07/2006
Ethics approval number [1] 2930 0
336
Ethics committee name [2] 2931 0
Cabrini Health
Ethics committee address [2] 2931 0
Ethics committee country [2] 2931 0
Australia
Date submitted for ethics approval [2] 2931 0
Approval date [2] 2931 0
25/05/2006
Ethics approval number [2] 2931 0
IEC ID 09-10-04-06
Ethics committee name [3] 2932 0
Royal Brisbane and Women's Hospital
Ethics committee address [3] 2932 0
Ethics committee country [3] 2932 0
Australia
Date submitted for ethics approval [3] 2932 0
Approval date [3] 2932 0
17/05/2006
Ethics approval number [3] 2932 0
IEC ID 2006/061
Ethics committee name [4] 2933 0
Southern Medical Day Care Centre
Ethics committee address [4] 2933 0
Ethics committee country [4] 2933 0
Australia
Date submitted for ethics approval [4] 2933 0
Approval date [4] 2933 0
31/05/2006
Ethics approval number [4] 2933 0
IEC ID CT06002
Ethics committee name [5] 2934 0
Burnside War Memorial Hospital
Ethics committee address [5] 2934 0
Ethics committee country [5] 2934 0
Australia
Date submitted for ethics approval [5] 2934 0
Approval date [5] 2934 0
01/06/2006
Ethics approval number [5] 2934 0
IEC ID NA

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35948 0
Address 35948 0
Country 35948 0
Phone 35948 0
Fax 35948 0
Email 35948 0
Contact person for public queries
Name 10389 0
Alana Chandler - Clinical Research Manager
Address 10389 0
Bayer Australia Limited
PO Box 903
Pymble NSW 2073
Country 10389 0
Australia
Phone 10389 0
+61 2 93916140
Fax 10389 0
Email 10389 0
[email protected]
Contact person for scientific queries
Name 1317 0
Jane Worrallo - Medical Services Manager
Address 1317 0
Bayer Australia Limited
PO Box 903
Pymble NSW 2073
Country 1317 0
Australia
Phone 1317 0
+61 2 93916147
Fax 1317 0
Email 1317 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.