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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
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)
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/show/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
Other publications