NeoplasmsPhase 1NCT00046735
Phase 1 Study OF CDC-501 in Patients With Solid Tumors
A Phase 1 study testing Lenalidomide in people with Neoplasms, run by Celgene at 1 site in United States.
Trial summary
To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2002to 28 Sep 2006
- 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
- Patient must understand and voluntarily sign an informed consent document.
- Age 18 years at the time of signing Informed Consent
- Histologically or cytologically documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.
- Patients must have at least one measurable or non-measurable lesion according to the RECIST Criteria (Appendix I).
- Patient has an ECOG (Zubrod) performance status of ≤ 2.
- Approximate life expectancy greater than 3 months.
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- Laboratory tests within these ranges:
- Absolute neutrophil count ≥ 1,500/μlL
- Platelet count ≥100,000/μL
- Serum creatinine ≤1.5 mg/dL
- Total bilirubin ≤1.5 mg/dL
- AST (SGOT)/ALT(SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases present
- The following prior treatments are allowable under this protocol:
- Radiation, if discontinued at least 4 weeks prior to treatment under this protocol Chemotherapy, if discontinued at least 4 weeks prior to treatment under this protocol, and at least 6 weeks prior to treatment under this protocol for prior nitrosurea or mitomycin-C treatment
- Hormonal therapy for cancer, if discontinued at least 4 weeks prior to treatment under this protocol
- Other investigational drugs, if discontinued at least 4 weeks prior to treatment under this protocol
- Surgery, if minor surgery occurred at least 2 weeks prior to treatment under this protocol, or at least 4 weeks since major surgery
- Patient must be able to adhere to the study visit schedule and other protocol requirements.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days prior to baseline. 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).
Who cannot join
- Myocardial infarction within the previous 6 months, unstable angina,symptomatic congestive heart failure, or other significant uncontrolled cardiac arrhythmia.
- Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event in the previous 6 months.
- Active infection, including known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
- CNS metastases, unless controlled by previous radiation and the patient is neurologically stable.
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or limit survival to less than 3 months.
- Pregnant or nursing females.Female patients of childbearing potential who are unwilling to use reliable contraceptive methods.
- Any condition, including the presence of laboratory abnormalities, which in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors
To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment.
Read the detailed description
Identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment
- Conditions
- Neoplasms
- Being tested
- Lenalidomide
- Keywords
- solid tumors, Revimid, CC5013, CC-5013
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
The planned doses for investigation are as follows: 5, 10, and 25 mg/day. Lenalidomide will be administered as a single daily dose for 4 weeks followed by a 2-week rest period. Dosing will be in the morning at approximately the same time each day, at least 1 hour before the morning meal. Patients will be assigned to dose level in the order of study entry. No dose adjustments or suspensions are allowed during the first cycle, except discontinuation for DLT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the MTD and safety of CDC-501 when given in a 6-wk cycle of daily administration of CDC-501 for 4 wks followed by a 2-wk rest in doses of 5 mg/day up to 25 mg/day in pts with solid tumors that are refractory after standard treatment.
Measured: 6-week cycle comprising daily administration of CDC-501 for 4 weeks followed by a 2-week rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2002 (estimated)
- Study start1 Jun 2002
- Primary completion1 Aug 2006
- Study completion28 Sep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Knight, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046735
- Sponsor's protocol ID
- CC-5013-ST-003
- Status last verified
- Nov 2019
- First submitted
- 2 Oct 2002
- Last updated
- 18 Nov 2019
- Results posted
- No
Publications
Miller AA, Case D, Harmon M, Savage P, Lesser G, Hurd D, Melin SA. Phase I study of lenalidomide in solid tumors. J Thorac Oncol. 2007 May;2(5):445-9. doi: 10.1097/01.JTO.0000268679.33238.67.
PubMed 17473661
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00046735
- Acronym / sponsor ID
- CC-5013-ST-003
- Conditions
- Neoplasms
- Keywords
- solid tumors, Revimid, CC5013, CC-5013
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2002 (actual)
- Primary completion
- 1 Aug 2006 (actual)
- Study completion
- 28 Sep 2006 (actual)
- First posted
- 3 Oct 2002 (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.
To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment.
Detailed description
Identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient must understand and voluntarily sign an informed consent document.
- Age 18 years at the time of signing Informed Consent
- Histologically or cytologically documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.
- Patients must have at least one measurable or non-measurable lesion according to the RECIST Criteria (Appendix I).
- Patient has an ECOG (Zubrod) performance status of ≤ 2.
Key exclusion criteria (7 listed)
- Myocardial infarction within the previous 6 months, unstable angina,symptomatic congestive heart failure, or other significant uncontrolled cardiac arrhythmia.
- Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event in the previous 6 months.
- Active infection, including known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
- CNS metastases, unless controlled by previous radiation and the patient is neurologically stable.
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or limit survival to less than 3 months.
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 |
|---|---|---|
| LenalidomideThe planned doses for investigation are as follows: 5, 10, and 25 mg/day. Lenalidomide will be administered as a single daily dose for 4 weeks followed by a 2-week rest period. Dosing will be in the morning at approximately the same time each day, at least 1 hour before the morning meal. Patients will be assigned to dose level in the order of study entry. No dose adjustments or suspensions are allowed during the first cycle, except discontinuation for DLT | Drug | 1 |
Primary outcome
To identify the MTD and safety of CDC-501 when given in a 6-wk cycle of daily administration of CDC-501 for 4 wks followed by a 2-wk rest in doses of 5 mg/day up to 25 mg/day in pts with solid tumors that are refractory after standard treatment.
Time frame: 6-week cycle comprising daily administration of CDC-501 for 4 weeks followed by a 2-week rest
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 18 Nov 2019.
- Background: PubMed 17473661Miller AA, Case D, Harmon M, Savage P, Lesser G, Hurd D, Melin SA. Phase I study of lenalidomide in solid tumors. J Thorac Oncol. 2007 May;2(5):445-9. doi: 10.1097/01.JTO.0000268679.33238.67.
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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.
Robert Knight, MD study director
Celgene Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide in people with Neoplasms, run by Celgene at 1 site 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 19 inclusion and 7 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
To identify the MTD and safety of CDC-501 when given in a 6-wk cycle of daily administration of CDC-501 for 4 wks followed by a 2-wk rest in doses of 5 mg/day up to 25 mg/day in pts with solid tumors that are refractory after standard treatment. (time frame: 6-week cycle comprising daily administration of CDC-501 for 4 weeks followed by a 2-week rest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00046735, which also lists 1 linked publication.
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 18 Nov 2019.