Non Small Cell Lung CancerPhase 1NCT00457119
Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients
A Phase 1 study testing RAD001 in people with Non Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 8 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 76 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- RAD001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Feb 2007to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)
- Ability to perform normal daily functions
Who cannot join
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States4 sites
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
Dallas, Texas, 75390-9151
MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc.
Houston, Texas, 77030-4009
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
New Orleans, Louisiana, 70115
Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114
Washington D.C., District of Columbia, 20007-2197
Australia2 sites
Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Heidelberg, Victoria, 3084
Germany2 sites
Novartis Investigative Site
Essen, 45122
Novartis Investigative Site
Heidelberg, 69126
About this study
Official 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
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
Read the detailed description
This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001 is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- RAD001
- Keywords
- Non Small Cell Lung Cancer, NSCLC, Advanced Lung Cancer, RAD, RAD001, chemotherapy, carboplatin, paclitaxel, bevacizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
Also called Everolimus
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
| Study group | Role | What they receive |
|---|---|---|
| Step 1 Arm 1 | Experimental | 5mg/day RAD001 + Carboplatin + Paclitaxel Receives: Drug: RAD001 |
| Step 1, Arm 2 | Experimental | 30mg/week RAD001 + Carboplatin + Paclitaxel Receives: Drug: RAD001 |
| Step 2, Arm 1 | Experimental | 5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab Receives: Drug: RAD001 |
| Step 2, Arm 2 | Experimental | 30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab Receives: Drug: RAD001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate
Measured: Ever 3 months or once a critical DLT occurs
Secondary outcomes (4)
Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)
Measured: End of step 1
Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)
Measured: End of Step 2
PK parameters derived from PK profiles of treatment drugs alone and in combination
Measured: End of Step 1 and Step 2
Best overall response - measured by CT/MRI scan every 6-8 week
Measured: Every 6-8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457119
- Sponsor's protocol ID
- CRAD001C2114
- Other IDs
- 2006-002760-26
- Status last verified
- Feb 2013
- First submitted
- 4 Apr 2007
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00457119
- Acronym / sponsor ID
- CRAD001C2114
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, NSCLC, Advanced Lung Cancer, RAD, RAD001, chemotherapy, carboplatin, paclitaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001 is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Step 1 Arm 1 | Experimental | Drug: RAD0015mg/day RAD001 + Carboplatin + Paclitaxel |
| Step 1, Arm 2 | Experimental | Drug: RAD00130mg/week RAD001 + Carboplatin + Paclitaxel |
| Step 2, Arm 1 | Experimental | Drug: RAD0015mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab |
| Step 2, Arm 2 | Experimental | Drug: RAD00130mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab |
Who may qualify
- Ages
- 23 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years
- Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)
- Ability to perform normal daily functions
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD001Also: Everolimus5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm | Drug | Step 1 Arm 1, Step 1, Arm 2, Step 2, Arm 1, Step 2, Arm 2 |
Primary outcome
Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate
Time frame: Ever 3 months or once a critical DLT occurs
4 secondary outcomes
Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)
Time frame: End of step 1
Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)
Time frame: End of Step 2
PK parameters derived from PK profiles of treatment drugs alone and in combination
Time frame: End of Step 1 and Step 2
Best overall response - measured by CT/MRI scan every 6-8 week
Time frame: Every 6-8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAD001 in people with Non Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate (time frame: Ever 3 months or once a critical DLT occurs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.