Renal Cell CarcinomaPhase 2NCT00036036
Study of CP-461 in Patients With Advanced Renal Cell Cancer
A Phase 2 study testing CP-461 in people with Renal Cell Carcinoma, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461 in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- CP-461
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jul 2003
- 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
- Measurable metastatic or locally advanced disease.
- Histologically confirmed renal cell cancer.
- No radiotherapy within 4 weeks prior to entering the study. No more than 1 prior systemic therapy for advanced disease. Prior adjuvant systemic therapy is allowed. Patients must have fully recovered from the acute effects of prior therapy.
- Expected remaining life span > or = three months.
- ECOG performance status 0-2.
- > or = 18 years of legal age.
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- Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal.
- Negative serum pregnancy test, if fertile female.
- Willingness and ability to sign an informed consent document.
Who cannot join
- Uncontrolled or symptomatic brain metastases.
- Use of an investigational medication or device within one month of initiating study therapy.
- Absolute granulocyte count < or = 1500/mm3; Platelet count < or = 100,000/mm3; total serum bilirubin above the upper limit of normal; serum creatinine > or = 2.2 mg/dL; AST/ALT > 2.5 ULN.
- Any condition or any medication which may interfere with the conduct of the study.
- Current active malignancy other than renal cell cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of CP-461 in Patients With Advanced Renal Cell Cancer
The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461 in this patient population.
- Conditions
- Renal Cell Carcinoma
- Being tested
- CP-461
- Keywords
- renal, renal cell cancer, renal cell carcinoma, kidney cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-461Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2002 (estimated)
- Study startJul 2001
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- 14 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036036
- Sponsor's protocol ID
- OSI-461-003
- Status last verified
- Oct 2011
- First submitted
- 7 May 2002
- Last updated
- 17 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of CP-461 in Patients With Advanced Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00036036
- Acronym / sponsor ID
- OSI-461-003
- Conditions
- Renal Cell Carcinoma
- Keywords
- renal, renal cell cancer, renal cell carcinoma, kidney cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Study start
- Jul 2001
- Study completion
- Jul 2003 (actual)
- First posted
- 8 May 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.
The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461 in this patient population.
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 (9 listed)
- Measurable metastatic or locally advanced disease.
- Histologically confirmed renal cell cancer.
- No radiotherapy within 4 weeks prior to entering the study. No more than 1 prior systemic therapy for advanced disease. Prior adjuvant systemic therapy is allowed. Patients must have fully recovered from the acute effects of prior therapy.
- Expected remaining life span > or = three months.
- ECOG performance status 0-2.
Key exclusion criteria (5 listed)
- Uncontrolled or symptomatic brain metastases.
- Use of an investigational medication or device within one month of initiating study therapy.
- Absolute granulocyte count < or = 1500/mm3; Platelet count < or = 100,000/mm3; total serum bilirubin above the upper limit of normal; serum creatinine > or = 2.2 mg/dL; AST/ALT > 2.5 ULN.
- Any condition or any medication which may interfere with the conduct of the study.
- Current active malignancy other than renal cell cancer.
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 |
|---|---|---|
| CP-461 | 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 17 Oct 2011.
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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 CP-461 in people with Renal Cell Carcinoma, run by Astellas Pharma Inc 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 9 inclusion and 5 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 17 Oct 2011. 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 17 Oct 2011.