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Prostate CancerPhase 2NCT00179738

A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid, CC-5013) in Subjects With Androgen Independent Prostate Cancer.

A Phase 2 study testing CC5013 in people with Prostate Cancer, run by Celgene Corporation at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Subjects who qualify will receive single agent oral lenalidomide daily on days 1-21 every 28 day cycle. Subjects will continue on study until documented disease progression Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
CC5013
How many people
40 participants
Where
6 sitesUnited States
Study dates
Apr 2005to Apr 2007
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
  • Men only
  • 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 histologic diagnosis of adenocarcinoma of the prostate.
  • Must be surgically or medically castrated. If the method is medical castration, the subject must have a serum testosterone level of <50 ng/dl. The subject should maintain treatment with LH RH antagonists or agonists.
  • Must have prostate cancer unresponsive or refractory to androgen blockade as demonstrated by rising PSA.
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  • -Rising PSA is defined as at least 2 consecutive rises in PSA to be documented over the reference value (measure 1). The first rising PSA (measure 2) must be taken at least 7 days after the reference value.
  • A third confirmatory PSA is required, and it must be obtained at least seven days after the second measure. If this is not greater than measure 2, a fourth PSA is required and this must be greater than measure 2.
  • -Absolute value of PSA > or = to 5 ng/ml on the last confirmatory assessment.
  • Prior treatment with antiandrogens such as flutamide, or other hormonal agents such as estrogens, corticosteroids, or ketoconazole must have been stopped for at least 28 days prior to treatment.
  • In the case of nilandron and bicalutamide, treatment with these agents must have stopped at least 42 days prior to treatment. Following completion of the antiandrogen withdrawal period, either:
  • One post withdrawal PSA value must be higher than the last pre-withdrawal PSA value, or
  • If the subject's PSA value decreased following the antiandrogen withdrawal period then two increases in PSA values must be documented after the post-withdrawal nadir.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix II: ECOG Performance Status Scale).

Who cannot join

  • Metastatic prostate cancer
  • 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)
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  • Serum total bilirubin >2.0 mg/dL (34 mmol/L)
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study.
  • Prior history of malignancies other than AIPC (except for basal cell or squamous cell carcinoma of the skin) 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.
  • Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
  • Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
  • Prior use of lenalidomide.
  • Prior use of chemotherapy for androgen independent prostate cancer.
  • Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy except LHRH agonists/antagonists.
  • Known active Hepatitis C.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Alta Bates Cancer Center

    Berkeley, California, 94704

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Moffit Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Multicenter, Single-Arm, Open-Label, Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®) In Subjects With Androgen Independent Prostate Cancer

Subjects who qualify will receive single agent oral lenalidomide daily on days 1-21 every 28 day cycle. Subjects will continue on study until documented disease progression

Conditions
Prostate Cancer
Being tested
CC5013
Keywords
Androgen Independent Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC5013Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the activity of lenalidomide monotherapy in subjects with androgen independent prostate cancer (AIPC).

Secondary outcomes (1)

  1. To evaluate the safety of lenalidomide monotherapy as treatment for subjects with AIPC.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Study completionApr 2007

Resources

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00179738
Sponsor's protocol ID
CC-5013-PC-001
Status last verified
Sep 2005
First submitted
10 Sep 2005
Last updated
23 Nov 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CC5013 in people with Prostate 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 14 inclusion and 16 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 23 Nov 2005. 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 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?

To determine the activity of lenalidomide monotherapy in subjects with androgen independent prostate cancer (AIPC).. 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 NCT00179738.

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 23 Nov 2005.

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