Small Cell Lung CancerPhase 2NCT00374140
Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer
A Phase 2 study testing RAD001 (everolimus) in people with Small Cell Lung Cancer, run by Ahmad Tarhini at 19 sites in United States.
Trial summary
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be administered orally at a dose of 10 mg daily. 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?
- RAD001 (everolimus)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 19 sitesUnited States
- Study dates
- Oct 2006to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cytologically or histologically confirmed small cell carcinoma of the lung that has progressed post first-line therapy. Mixed small and non-small cell tumors are excluded.
- Prior chemotherapy for small cell carcinoma. Up to 2 prior chemotherapy regimens for small cell lung carcinoma are allowed. No prior therapy with an m-TOR inhibitor (e.g. CCI-779).
- Unidimensionally measurable disease (RECIST criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
- ECOG performance status 0-2.
- A minimum of 4 weeks should elapse from prior chemotherapy. Patients must have fully recovered from the effects of any prior surgery or radiation therapy or other anticancer therapies, including immunotherapy and investigational agents.
- No progressive brain metastases. Brain metastases should have been previously treated with surgery and/or radiation.
Show all 16Show fewer
- Patients with a prior malignancy should have at least 3 years of disease-free survival. Prior curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer or other in situ malignancies are allowed.
- No other coexisting medical condition that would preclude full compliance with the study.
- Required laboratory values (obtained < 1 week prior to enrollment):
- ANC >/= 1500/mm³
- Platelets >/= 100,000/mm³
- AST and ALT ≤ 3 x ULN (upper limits of normal). In patients with liver metastases AST and ALT should be < 5 x ULN.
- Total bilirubin up to 1.5 x ULN (upper limits of normal).
- Age >/= 18 years and capacity to give informed consent.
- Patients should be advised to discontinue drugs that interact with CYP3A4 (see list of examples in Table 3.1 of the full protocol), if medically safe.
- All patients must have given signed, informed consent prior to registration on study.
Who cannot join
- Prior treatment with any investigational agent within the preceding 4 weeks.
- Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).
- A known history of HIV seropositivity.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
- Patients with an active, bleeding diathesis or on anticoagulation (except low dose warfarin).
- Pregnant and lactating women are excluded from the study because the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk.
- Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study.
- Patients should not be on chronic systemic glucocorticoids or other immunosuppressant.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
UPMC Cancer Center - Beaver
Beaver, Pennsylvania, 15009
UPMC Cancer Center - Clairton
Clairton, Pennsylvania, 15025
UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg
Greensburg, Pennsylvania, 15601
UPMC Cancer Center - Oakbrook Commons - Greensburg
Greensburg, Pennsylvania, 15601
UPMC Cancer Center - Indiana
Indiana, Pennsylvania, 15701
UPMC Cancer Center - John P. Murtha Pavilion - Johnstown
Johnstown, Pennsylvania, 15901
UPMC Cancer Center - McKeesport
McKeesport, Pennsylvania, 15132
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
UPMC Cancer Center - Sewickley Medical Oncology/Hematology Group
Moon Township, Pennsylvania, 15108
UPMC Cancer Center - New Castle
New Castle, Pennsylvania, 16105
UPMC Cancer Center - St. Margaret's
Pittsburgh, Pennsylvania, 15215
UPMC Cancer Center - Mercy
Pittsburgh, Pennsylvania, 15219
University of Pittsburgh Cancer Institute - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UPMC Cancer Center - Passavant
Pittsburgh, Pennsylvania, 15237
UPMC Cancer Center - Upper St. Clair
Pittsburgh, Pennsylvania, 15241
UPMC Cancer Center - Teramana Cancer Center - Steubenville
Steubenville, Ohio, 43952
UPMC Cancer Center - Uniontown
Uniontown, Pennsylvania, 15401
UPMC Cancer Center - Washington
Washington, Pennsylvania, 15301
UPMC Cancer Center - North Hills
Wexford, Pennsylvania, 15090
About this study
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be administered orally at a dose of 10 mg daily.
Read the detailed description
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. Patients may have received up to 2 prior chemotherapy regimens for small cell lung carcinoma, but no prior therapy with an m-TOR inhibitor. RAD001 will be administered orally at a dose of 10 mg daily. A cycle will be defined as 3 weeks of study drug administration, and patients will have tumor measurements every 2 cycles. Study participation will continue until disease progression or intolerable toxicities. In addition, in patients who consent, archival tumor tissue (paraffin block from original biopsy) will be collected for research purposes.
- Conditions
- Small Cell Lung Cancer
- Being tested
- RAD001 (everolimus)
- Keywords
- small cell, lung
- 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.
RAD001 (everolimus)Drug
Also called Certican®
10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
| Study group | Role | What they receive |
|---|---|---|
| RAD001 (Everolimus) | Experimental | RAD001 (Everolimus)10 mg by mouth daily without interruption Receives: Drug: RAD001 (everolimus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.
Measured: Two cycles of treatment with RAD001 (~6 weeks)
Secondary outcomes (3)
Overall Survival
Measured: From entry in trial to up to 60 months
Progression-free Survival
Measured: From entry into trial to up to 60 months
Objective Response Rate
Number of patients for which response to treatment was observed / total number of patients.
Measured: From beginning of treatment up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2008
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Tarhini
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Ahmad Tarhini, University of Pittsburgh
- Investigators
- Ahmad Tarhini, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374140
- Sponsor's protocol ID
- 06-049
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2006
- Last updated
- 19 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00374140
- Acronym / sponsor ID
- 06-049
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell, lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ahmad TarhiniUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Oct 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Posted 27 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be administered orally at a dose of 10 mg daily.
Detailed description
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. Patients may have received up to 2 prior chemotherapy regimens for small cell lung carcinoma, but no prior therapy with an m-TOR inhibitor. RAD001 will be administered orally at a dose of 10 mg daily. A cycle will be defined as 3 weeks of study drug administration, and patients will have tumor measurements every 2 cycles. Study participation will continue until disease progression or intolerable toxicities. In addition, in patients who consent, archival tumor tissue (paraffin block from original biopsy) will be collected for research purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001 (Everolimus) | Experimental | Drug: RAD001 (everolimus)RAD001 (Everolimus)10 mg by mouth daily without interruption |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Cytologically or histologically confirmed small cell carcinoma of the lung that has progressed post first-line therapy. Mixed small and non-small cell tumors are excluded.
- Prior chemotherapy for small cell carcinoma. Up to 2 prior chemotherapy regimens for small cell lung carcinoma are allowed. No prior therapy with an m-TOR inhibitor (e.g. CCI-779).
- Unidimensionally measurable disease (RECIST criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
- ECOG performance status 0-2.
- A minimum of 4 weeks should elapse from prior chemotherapy. Patients must have fully recovered from the effects of any prior surgery or radiation therapy or other anticancer therapies, including immunotherapy and investigational agents.
Key exclusion criteria (8 listed)
- Prior treatment with any investigational agent within the preceding 4 weeks.
- Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).
- A known history of HIV seropositivity.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
- Patients with an active, bleeding diathesis or on anticoagulation (except low dose warfarin).
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 (everolimus)Also: Certican®10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities | Drug | RAD001 (Everolimus) |
Primary outcome
Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.
Time frame: Two cycles of treatment with RAD001 (~6 weeks)
3 secondary outcomes
Overall Survival
Time frame: From entry in trial to up to 60 months
Progression-free Survival
Time frame: From entry into trial to up to 60 months
Objective Response Rate
Time frame: From beginning of treatment up to 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ahmad Tarhini, MD, PhD principal investigator
University of Pittsburgh
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAD001 (everolimus) in people with Small Cell Lung Cancer, run by Ahmad Tarhini at 19 sites in United States.
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 16 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001. (time frame: Two cycles of treatment with RAD001 (~6 weeks)). 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 19 Oct 2017.