Non-Small Cell Lung CancerPhase 2NCT00179686
A Study to Evaluate the Single-Agent Lenalidomide in Subjects With Recurrent Non-Small-Cell Lung Cancer
A Phase 2 study testing CC-5013 in people with Non-Small Cell Lung Cancer, run by Celgene Corporation at 6 sites in United States.
Trial summary
Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day cycles. Subjects will continue until disease progression is documented. 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?
- CC-5013
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2005to Jul 2006
- Phase
- Phase 2
- 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
- Understand and voluntarily sign an informed consent form.
- Age >or = to 18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Must have a histologically confirmed diagnosis of non small cell lung cancer that has recurred following at least two prior regimens. Those regimens must have contained both a platinum compound and a taxane either sequentially or in combination
- Subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix II).
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.
- WCBP must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug.
Who cannot join
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
- Platelet count <100,000/mm3 (100 x 109/L)
- Serum creatinine >2.5 mg/dL (221 mmol/L)
- Serum SGOT/AST or SGPT/ALT >5.0 x upper limit of normal (ULN)
- Serum total bilirubin >2.0 mg/dL (34 mmol/L)
Show all 14Show fewer
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or = to 1 year.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- Prior > or = grade 3 allergic reaction/hypersensitivity to thalidomide.
- Prior > or = grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
- Prior use of lenalidomide.
- Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Birmingham Cancer Center
Birmingham, Alabama, 35294
Rush Cancer Institute
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
MD Anderson Cancer Center
Houston, Texas, 77030
Cancer and Blood Institute
Metairie, Louisiana, 70006
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid, CC-5013) in Subjects With Recurrent Non-Small Cell Lung Cancer
Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day cycles. Subjects will continue until disease progression is documented.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- CC-5013
- Keywords
- celgene, cc-5013, NSCLC, CC5013, Revlimid, Non-Small Cell Lung Cancer
- 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.
CC-5013Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the activity of lenalidiomide in recurrent non-small cell lung cancer. Activity will be assessed by measuring the response rate, tumor control rate, and time to tumor progression.
Secondary outcomes (1)
To evaluate the safety of lenalidomide monotherapy as treatment for subjects with recurrent non-small cell lung cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2005
- Study completionJul 2006
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prologue Research International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179686
- Sponsor's protocol ID
- CC-5013-NSCL-001
- Status last verified
- Dec 2006
- First submitted
- 10 Sep 2005
- Last updated
- 20 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid, CC-5013) in Subjects With Recurrent Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00179686
- Acronym / sponsor ID
- CC-5013-NSCL-001
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- celgene, cc-5013, NSCLC, CC5013, Revlimid, Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Prologue Research International
- Study start
- Mar 2005
- Study completion
- Jul 2006
- First posted
- 16 Sep 2005 (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.
Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day cycles. Subjects will continue until disease progression is documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Understand and voluntarily sign an informed consent form.
- Age >or = to 18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Must have a histologically confirmed diagnosis of non small cell lung cancer that has recurred following at least two prior regimens. Those regimens must have contained both a platinum compound and a taxane either sequentially or in combination
- Subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter.
Key exclusion criteria (14 listed)
- Any of the following laboratory abnormalities:
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or = to 1 year.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
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 |
|---|---|---|
| CC-5013 | Drug | – |
Primary outcome
To determine the activity of lenalidiomide in recurrent non-small cell lung cancer. Activity will be assessed by measuring the response rate, tumor control rate, and time to tumor progression.
1 secondary outcome
To evaluate the safety of lenalidomide monotherapy as treatment for subjects with recurrent non-small cell lung cancer.
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 20 Dec 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 CC-5013 in people with Non-Small Cell Lung Cancer, run by Celgene Corporation at 6 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 8 inclusion and 14 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 20 Dec 2006. 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. 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?
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?
To determine the activity of lenalidiomide in recurrent non-small cell lung cancer. Activity will be assessed by measuring the response rate, tumor control rate, and time to tumor progression.. 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 20 Dec 2006.