Non Small Cell Lung CancerPhase 1NCT00456833
Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy
A Phase 1 study testing RAD001 and erlotinib in people with Non Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 14 sites in 5 countries.
Trial summary
This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- RAD001 and erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Jun 2005to Mar 2011
- 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 18 to 80 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 which is not responding to chemotherapy treatment including either cisplatin or carboplatin
- Only 1-2 previous chemotherapy regimens for advanced disease
- More than 2 weeks from previous surgery, radiation or chemotherapy
- Ability to perform normal daily functions
Who cannot join
- Chronic steroid treatment
- Prior treatment with EGFR inhibitors
- Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions or other severe medical conditions
- Other cancers within the past 2 years
- Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
United States7 sites
Novartis Investigative Site
Atlanta, Georgia, 30322
Novartis Investigative Site
Boston, Massachusetts, 02115
Novartis Investigative Site
Chicago, Illinois, 60637-1470
Novartis Investigative Site
Houston, Texas, 77030-4009
Novartis Investigative Site
Madison, Wisconsin, 53792
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
Rochester, Minnesota, 55905
Canada3 sites
Novartis Investigative Site
Montreal, Quebec, H2L 4M1
Novartis Investigative Site
Richmond, British Columbia, V7C 5L9
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
France2 sites
Novartis Investigative Site
Saint-Herblain Cédex, 44805
Novartis Investigative Site
Villejuif, 94805
About this study
Official title: A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy
This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- RAD001, erlotinib
- Keywords
- Non Small Cell Lung Cancer, NSCLC, Advanced lung cancer, RAD, RAD001, erlotinib
- 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
erlotinibDrug
| Study group | Role | What they receive |
|---|---|---|
| RAD 5mg/day + erlotinib | Experimental | Not described Receives: Drug: RAD001 |
| erlotinib 150mg/day | Active comparator | Not described Receives: Drug: RAD001; Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.
Measured: first 28 days of combined treatment
Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1
Measured: at baseline and after 8 weeks of treatment
Secondary outcomes (3)
Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression
Measured: at baseline, monthly until month 4 then q2months until progression
Phase 2: Safety and steady state drug levels evaluated monthly
Measured: Monthly
Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue
Measured: Dec 2009
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 startJun 2005
- Primary completionMar 2011
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456833
- Sponsor's protocol ID
- CRAD001C2111
- Other IDs
- 2004-003017-16, 2004
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2007
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy
- ClinicalTrials.gov ID
- NCT00456833
- Acronym / sponsor ID
- CRAD001C2111
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, NSCLC, Advanced lung cancer, RAD, RAD001, erlotinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Mar 2011 (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 study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAD 5mg/day + erlotinib | Experimental | Drug: RAD001 |
| erlotinib 150mg/day | Active comparator | Drug: RAD001, Drug: erlotinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years
- Advanced Non Small Cell Lung Cancer which is not responding to chemotherapy treatment including either cisplatin or carboplatin
- Only 1-2 previous chemotherapy regimens for advanced disease
- More than 2 weeks from previous surgery, radiation or chemotherapy
- Ability to perform normal daily functions
Key exclusion criteria (5 listed)
- Chronic steroid treatment
- Prior treatment with EGFR inhibitors
- Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions or other severe medical conditions
- Other cancers within the past 2 years
- Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| RAD001 | Drug | RAD 5mg/day + erlotinib, erlotinib 150mg/day |
| erlotinib | Drug | erlotinib 150mg/day |
Primary outcome
Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.
Time frame: first 28 days of combined treatment
Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1
Time frame: at baseline and after 8 weeks of treatment
3 secondary outcomes
Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression
Time frame: at baseline, monthly until month 4 then q2months until progression
Phase 2: Safety and steady state drug levels evaluated monthly
Time frame: Monthly
Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue
Time frame: Dec 2009
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 21 Dec 2020.
- Results for CRAD001C2111 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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
Novartis Pharmaceuticals study director
Novartis Pharmeceuticals
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAD001 and erlotinib in people with Non Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 14 sites in 5 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 5 inclusion and 5 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, France, Denmark, Russia. 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?
Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose. (time frame: first 28 days of combined treatment). The study lists 2 primary outcomes in all. 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 21 Dec 2020.