Small-Cell Lung CancerPhase 1NCT00466466
Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients
A Phase 1 study testing Everolimus in people with Small-Cell Lung Cancer, run by Novartis Pharmaceuticals at 6 sites in 2 countries.
Trial summary
This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-Cell Lung Cancer
- What is being tested?
- Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Apr 2007to Nov 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
- Patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ED SCLC)
- Age ≥ 18 years
- WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions)
- Adequate bone marrow, liver and renal function
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
- Symptomatic or uncontrolled brain metastases
- Other cancers within the past 5 years
- Pregnant or breastfeeding women
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80045
Dana Faber Cancer Institute
Boston, Massachusetts, 02115
Highlands Oncology Group
Fayetteville, Arkansas, 72703
MD Anderson Cancer Center
Houston, Texas, 77030-4009
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, 78229
About this study
Official title: A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy
This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.
- Conditions
- Small-Cell Lung Cancer
- Being tested
- Everolimus
- Keywords
- Small-Cell Lung Cancer, SCLC, Advanced Lung Cancer, RAD, RAD001, Chemotherapy, Cisplatin, Etoposide
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called RAD001
RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.
| Study group | Role | What they receive |
|---|---|---|
| Daily dosing RAD001 | Experimental | Not described Receives: Drug: Everolimus |
| Weekly dosing RAD001 | Experimental | Not described Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1
Measured: Day 21
Secondary outcomes (3)
Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen
Measured: within 6 cycles (Day 126)
PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles
Measured: During the first 6 cycles
Overall tumor response
Measured: Every 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT00466466
- Sponsor's protocol ID
- CRAD001C2116
- Status last verified
- Nov 2011
- First submitted
- 26 Apr 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 Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT00466466
- Acronym / sponsor ID
- CRAD001C2116
- Conditions
- Small-Cell Lung Cancer
- Keywords
- Small-Cell Lung Cancer, SCLC, Advanced Lung Cancer, RAD, RAD001, Chemotherapy, Cisplatin, Etoposide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Nov 2010 (actual)
- First posted
- 27 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 establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily dosing RAD001 | Experimental | Drug: Everolimus |
| Weekly dosing RAD001 | Experimental | Drug: Everolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ED SCLC)
- Age ≥ 18 years
- WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions)
- Adequate bone marrow, liver and renal function
Key exclusion criteria (8 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
- Symptomatic or uncontrolled brain metastases
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: RAD001RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language. | Drug | Daily dosing RAD001, Weekly dosing RAD001 |
Primary outcome
Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1
Time frame: Day 21
3 secondary outcomes
Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen
Time frame: within 6 cycles (Day 126)
PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles
Time frame: During the first 6 cycles
Overall tumor response
Time frame: Every 6-8 weeks
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 CRAD001C2116 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
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Everolimus in people with Small-Cell Lung Cancer, run by Novartis Pharmaceuticals at 6 sites in 2 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 4 inclusion and 8 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 6 sites in United States, France. 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?
Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1 (time frame: Day 21). 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.