Non Small Cell Lung CancerPhase 1NCT00434174
Safety of Everolimus and Pemetrexed in Lung Cancer Patients
A Phase 1 study testing Everolimus and Pemetrexed in people with Non Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 5 sites in 3 countries.
Trial summary
This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Everolimus and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Dec 2006to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lung cancer
- Only one prior regimen of chemotherapy for the treatment of non small cell lung cancer
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Negative serum pregnancy test
Who cannot join
- History of another primary malignancy in the last 5 years
- Having recently received an investigational drug
- Having recently received major surgery of wide field radiotherapy
- Chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators
- Severe or uncontrolled medical conditions
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Australia2 sites
Novartis Investigative Site
Camperdown, New South Wales, 2050
Novartis Investigative Site
Melbourne, Victoria, 3002
Germany2 sites
Novartis Investigative Site
Cologne, 50924
Novartis Investigative Site
Hamburg, 20246
About this study
Official title: A Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy
This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Everolimus, Pemetrexed
- Keywords
- Lung cancer, Non small cell lung cancer, NSCLC, RAD001, Everolimus, Afinitor, Pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called RAD001, Affinitor
RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. All proposed dose levels in this study can be given as a combination of these dose strengths.
Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed.
PemetrexedDrug
Pemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline
| Study group | Role | What they receive |
|---|---|---|
| everolimus + Pemetrexed - daily | Experimental | Daily treatment Receives: Drug: Everolimus; Drug: Pemetrexed |
| everolimus + Pemetrexed - weekly | Experimental | Weekly treatment Receives: Drug: Everolimus; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
Measured: Over 18 weeks of combination treatment
Secondary outcomes (1)
Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST)
Measured: Over 18 weeks of combination treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2010
- Study completionDec 2010
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
- 48 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, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434174
- Sponsor's protocol ID
- CRAD001C2112
- Other IDs
- 2006-002759-34
- Status last verified
- Dec 2012
- First submitted
- 9 Feb 2007
- Last updated
- 21 Dec 2020
- Results posted
- 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 Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT00434174
- Acronym / sponsor ID
- CRAD001C2112
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Lung cancer, Non small cell lung cancer, NSCLC, RAD001, Everolimus, Afinitor, Pemetrexed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Feb 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 will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| everolimus + Pemetrexed - daily | Experimental | Drug: Everolimus, Drug: PemetrexedDaily treatment |
| everolimus + Pemetrexed - weekly | Experimental | Drug: Everolimus, Drug: PemetrexedWeekly treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Lung cancer
- Only one prior regimen of chemotherapy for the treatment of non small cell lung cancer
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
Key exclusion criteria (6 listed)
- History of another primary malignancy in the last 5 years
- Having recently received an investigational drug
- Having recently received major surgery of wide field radiotherapy
- Chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators
- Severe or uncontrolled medical conditions
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 |
|---|---|---|
| EverolimusAlso: RAD001, AffinitorRAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. All proposed dose levels in this study can be given as a combination of these dose strengths. Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed. | Drug | everolimus + Pemetrexed - daily, everolimus + Pemetrexed - weekly |
| PemetrexedPemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline | Drug | everolimus + Pemetrexed - daily, everolimus + Pemetrexed - weekly |
Primary outcome
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
Time frame: Over 18 weeks of combination treatment
1 secondary outcome
Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST)
Time frame: Over 18 weeks of combination treatment
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 CRAD001C2112 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 study chair
Novartis
5 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 Everolimus and Pemetrexed in people with Non Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 5 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 6 inclusion and 6 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 5 sites in Australia, Germany, Belgium. 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 feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate. (time frame: Over 18 weeks of combination treatment). 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.