Ovarian CancerPhase 1/2NCT00179725
Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid® CC-5013) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma
A Phase 1/2 study testing CC-5013 and liposomal doxorubicin in people with Ovarian Cancer, run by Celgene Corporation at 5 sites in United States.
Trial summary
Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-21 when given with liposomal doxorubicin on day 1 of every 28 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-21 with liposomal… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- CC-5013 and liposomal doxorubicin
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2005to Jun 2007
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must understand and voluntarily sign an informed consent document.
- Age > or = to 18 years at the time of signing informed consent form.
- Subjects must be able to adhere to the study visit schedule and other protocol requirements.
- Histological or cytological documentation of advanced ovarian or primary peritoneal carcinoma.
- Radiographic or clinical evidence of measurable metastatic advanced ovarian or primary peritoneal carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
- Subjects must have been treated and progressed following chemotherapy which includes platinum and paclitaxel.
- ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
- Must have 2-d Echocardiogram/MUGA indicating a LVEF above the institutional lower limit of normal within 42 days prior to first 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 cells/mm3 (100 x 109/L)
- Serum creatinine >2.5 mg/dL (221 mmol/L)
- Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
- Serum total bilirubin >1.2 mg/dL (20 mmol/L)
Show all 17Show fewer
- Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
- Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for > or = to 1 years.
- Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
- More than 1 prior chemotherapy regimen. However, subjects with platinum sensitive disease (i.e., subjects who fail a platinum containing regimen at least six months after completing the regimen) who are retreated with a platinum containing regimen are eligible.
- Concurrent use of any other anti-cancer agents.
- Any prior use of Lenalidomide.
- Prior > or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
- Prior > or = grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
- Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
- History of cardiac disease, with New York Heart Association Class II or greater (see Appendix V).
- Subjects who have received > 200mg/m2 of anthracycline or anthracendione either alone or in combination. (Additional caution must be taken in subjects with mediastinal radiation.)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
OU Health Sciences Center
Oklahoma City, Oklahoma, 73104
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806
University of California at San Francisco
San Francisco, California, 94115
Swedish Cancer Institute
Seattle, Washington, 98104
About this study
Official title: Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid®) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma
Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-21 when given with liposomal doxorubicin on day 1 of every 28 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-21 with liposomal doxorubicinon day 1 in 28 day cycles until disease progression is documented.
- Conditions
- Ovarian Cancer
- Being tested
- CC-5013, liposomal doxorubicin
- Keywords
- cc-5013, revlimid, ovarian cancer, celgene
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-5013Drug
liposomal doxorubicinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days, as combination therapy to subjects with advanced ovarian or primary peritoneal ca
Phase II-To explore the anti-tumor activity of the combination of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days when given to subjects with advanced ovarian or primary peritoneal carcinoma.
Secondary outcomes (2)
Phase I-To explore the anti-tumor activity of the combination of lenalidomide and liposomal doxorubicin when given to subjects with advanced ovarian or primary peritoneal carcinoma.
Phase II-To evaluate the safety profile of the combination of lenalidomide and liposomal doxorubicin when given to subjects with advanced ovarian or primary peritoneal carcinoma
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 startNov 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT00179725
- Sponsor's protocol ID
- CC-5013-OVRY-001
- Status last verified
- Apr 2006
- First submitted
- 10 Sep 2005
- Last updated
- 12 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid®) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT00179725
- Acronym / sponsor ID
- CC-5013-OVRY-001
- Conditions
- Ovarian Cancer
- Keywords
- cc-5013, revlimid, ovarian cancer, celgene
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Prologue Research International
- Study start
- Nov 2005
- Study completion
- Jun 2007
- 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.
Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-21 when given with liposomal doxorubicin on day 1 of every 28 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-21 with liposomal doxorubicinon day 1 in 28 day cycles until disease progression is documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must understand and voluntarily sign an informed consent document.
- Age > or = to 18 years at the time of signing informed consent form.
- Subjects must be able to adhere to the study visit schedule and other protocol requirements.
- Histological or cytological documentation of advanced ovarian or primary peritoneal carcinoma.
- Radiographic or clinical evidence of measurable metastatic advanced ovarian or primary peritoneal carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
Key exclusion criteria (17 listed)
- Any of the following laboratory abnormalities:
- Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
- Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for > or = to 1 years.
- Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
- More than 1 prior chemotherapy regimen. However, subjects with platinum sensitive disease (i.e., subjects who fail a platinum containing regimen at least six months after completing the regimen) who are retreated with a platinum containing regimen are eligible.
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 | – |
| liposomal doxorubicin | Drug | – |
Primary outcome
Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days, as combination therapy to subjects with advanced ovarian or primary peritoneal ca
Phase II-To explore the anti-tumor activity of the combination of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days when given to subjects with advanced ovarian or primary peritoneal carcinoma.
2 secondary outcomes
Phase I-To explore the anti-tumor activity of the combination of lenalidomide and liposomal doxorubicin when given to subjects with advanced ovarian or primary peritoneal carcinoma.
Phase II-To evaluate the safety profile of the combination of lenalidomide and liposomal doxorubicin when given to subjects with advanced ovarian or primary peritoneal carcinoma
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CC-5013 and liposomal doxorubicin in people with Ovarian Cancer, run by Celgene Corporation at 5 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 17 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: stopped early, as of the sponsor's last update on 12 Apr 2006. 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 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 combined 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.
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 was stopped early. Results are not available in the source record.
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?
Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days, as combination therapy to subjects with advanced ovarian or primary peritoneal ca. The study lists 2 primary outcomes in all. 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 12 Apr 2006.