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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00457119




Registration number
NCT00457119
Ethics application status
Date submitted
4/04/2007
Date registered
5/04/2007
Date last updated
12/02/2013

Titles & IDs
Public title
Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients
Scientific title
A Two-step Phase 1 Study Investigating the Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients Not Treated Previously With Systemic Therapy
Secondary ID [1] 0 0
2006-002760-26
Secondary ID [2] 0 0
CRAD001C2114
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 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 - RAD001

Experimental: Step 1 Arm 1 - 5mg/day RAD001 + Carboplatin + Paclitaxel

Experimental: Step 1, Arm 2 - 30mg/week RAD001 + Carboplatin + Paclitaxel

Experimental: Step 2, Arm 1 - 5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab

Experimental: Step 2, Arm 2 - 30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab


Treatment: Drugs: RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate
Timepoint [1] 0 0
Ever 3 months or once a critical DLT occurs
Secondary outcome [1] 0 0
Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)
Timepoint [1] 0 0
End of step 1
Secondary outcome [2] 0 0
Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)
Timepoint [2] 0 0
End of Step 2
Secondary outcome [3] 0 0
PK parameters derived from PK profiles of treatment drugs alone and in combination
Timepoint [3] 0 0
End of Step 1 and Step 2
Secondary outcome [4] 0 0
Best overall response - measured by CT/MRI scan every 6-8 week
Timepoint [4] 0 0
Every 6-8 week

Eligibility
Key inclusion criteria
Inclusion criteria:

* Age over 18 years
* Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)
* Ability to perform normal daily functions
Minimum age
23 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Chronic steroid treatment
* Prior treatment with chemotherapy for advanced lung cancer
* Prior treatment with mTOR inhibitors
* Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions
* Known sensitivity to platinum compounds, taxanes or bevacizumab
* Other cancers within the past 5 years
* Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Germany
State/province [4] 0 0
Essen
Country [5] 0 0
Germany
State/province [5] 0 0
Heidelberg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab
Trial website
https://clinicaltrials.gov/study/NCT00457119
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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/study/NCT00457119