Prostate CancerPhase 2NCT00081601
Study of CEP-701 in Treatment of Prostate Cancer
A Phase 2 study testing CEP-701 in people with Prostate Cancer, run by Cephalon at 1 site in United States.
Trial summary
The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85. 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?
- CEP-701
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jun 2005
- 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
- at least 18 yrs of age
- diagnosis of adenocarcinoma of the prostate
- no detectable metastatic disease as assessed by bone and CT scans
- has increasing serum PSA concentrations
- life expectancy of at least 3 months
- ECOG of 0 or 1
- has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period
Who cannot join
- has asymptomatic disease
- has active GI ulceration or bleeding
- has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
- bilirubin >2x ULN or ALT or AST >2xULN or serum creatinine >1.5mg/dL
- hemoglobin <9g/dL or platelets below 100,000/uL or ANC below 1500/uL
- receiving treatment for HIV with protease inhibitors
- has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
- has used investigational drug with previous one month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen
The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.
Read the detailed description
A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.
- Conditions
- Prostate Cancer
- Being tested
- CEP-701
- Keywords
- prostate cancer, prostate specific antigen, PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEP-701Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2004 (estimated)
- Study startMar 2004
- Primary completionMay 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- 30 participants
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081601
- Sponsor's protocol ID
- C0701a/203/ON/US
- Status last verified
- Aug 2012
- First submitted
- 15 Apr 2004
- Last updated
- 24 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen
- ClinicalTrials.gov ID
- NCT00081601
- Acronym / sponsor ID
- C0701a/203/ON/US
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate specific antigen, PSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- May 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 19 Apr 2004 (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.
The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.
Detailed description
A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.
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
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- at least 18 yrs of age
- diagnosis of adenocarcinoma of the prostate
- no detectable metastatic disease as assessed by bone and CT scans
- has increasing serum PSA concentrations
- life expectancy of at least 3 months
Key exclusion criteria (8 listed)
- has asymptomatic disease
- has active GI ulceration or bleeding
- has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
- bilirubin >2x ULN or ALT or AST >2xULN or serum creatinine >1.5mg/dL
- hemoglobin <9g/dL or platelets below 100,000/uL or ANC below 1500/uL
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 |
|---|---|---|
| CEP-701 | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Aug 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CEP-701 in people with Prostate Cancer, run by Cephalon 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 7 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 24 Aug 2012. 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 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.
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 24 Aug 2012.