Malignant MelanomaPhase 2NCT00060710
CP-461 in the Treatment of Patients With Advanced Melanoma
A Phase 2 study testing CP-461 in people with Malignant Melanoma, 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 patients with advanced or metastatic malignant melanoma 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
- Malignant Melanoma
- What is being tested?
- CP-461
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Dec 2004
- 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
- Histologically confirmed malignant melanoma that is advanced or metastatic.
- Patients may have received up to 2 prior systemic chemotherapy regimens (including dacarbazine, and alternative dosing schedule of temozolomide). The last chemotherapy must have been at least 4 weeks prior to study drug administration.
- Prior radiation therapy will be allowed. Radiotherapy must have been completed at least 4 weeks prior to study drug administration.
- Patients may have received prior surgery. At least 4 weeks must have elapsed and patients must have recovered from all side effects associated with surgery.
- Patients with measurable disease. At least one bidimensionally measurable lesion with clearly defined margins documented by: medical photograph for skin and oral lesions, plain X-ray with at least one diameter 0.5 cm or greater, CT, MRI, or palpation with both diameters 2 cm or greater. A radiated bony lesion may not be considered an evaluable lesion, unless there is evidence of disease progression at that site prior to administration of study drug.
- Clinical parameters: Life expectancy > 2 months, Age >18 years, ECOG performance status 0-2
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- Patients should have adequate organ function related to the following: White count > 3000/ul, Platelet count > 70,000/ul, Hemoglobin > 8 g/l, Bilirubin WNL, AST and ALT < 2.5 x ULN, and Creatinine < 1.5 x ULN or 24 hour creatinine clearance > 60 ml/min
- There should be no acute infection requiring systemic antibiotics.
- Informed consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
Who cannot join
- Subjects who have brain metastases.
- More than 2 prior chemotherapy regimens for the treatment of advanced melanoma.
- Chemotherapy within four weeks prior to study drug administration.
- Radiation therapy to greater than or equal to 50% of the bone marrow. Patients must not have had prior radiotherapy to areas of measurable disease unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation.
- Insufficient recovery from all active toxicities of prior therapies.
- Subjects who are poor medical risks because of active nonmalignant systemic disease.
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- Frequent vomiting or medical condition that could interfere with oral medication intake (e.g. partial bowel obstruction).
- No prior malignancy other than curatively treated carcinoma in-situ of the cervix or skin cancer. If in the opinion of the treating physician, sufficient time has elapsed, such that it is extremely likely that the patient has been cured of a prior malignancy, the patient may be eligible for the protocol.
- No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g. serious infection). HIV status or other severe illnesses will be assessed using medical records.
- Pregnant or nursing women. Both women and men must take adequate precautions to prevent pregnancy during treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Presbyterian Medical Center
New York, New York, 10032
About this study
Official title: Phase II Study of CP-461 in the Treatment of Patients With Advanced Melanoma
The purpose of this study is to determine the efficacy of CP-461 given twice daily orally in patients with advanced or metastatic malignant melanoma and to evaluate the safety profile of CP-461 in this patient population.
- Conditions
- Malignant Melanoma
- Being tested
- CP-461
- Keywords
- melanoma
- Medical subject headings
- Melanoma
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 posted13 May 2003 (estimated)
- Study startJan 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies 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
- 35 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cell Pathways, OSI Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060710
- Sponsor's protocol ID
- OSI-461-013
- Status last verified
- Oct 2011
- First submitted
- 9 May 2003
- 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 the Treatment of Patients With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00060710
- Acronym / sponsor ID
- OSI-461-013
- Conditions
- Malignant Melanoma
- Keywords
- melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 35 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Cell Pathways, OSI Pharmaceuticals
- Study start
- Jan 2003
- Study completion
- Dec 2004 (actual)
- First posted
- 13 May 2003 (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 patients with advanced or metastatic malignant melanoma 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)
- Histologically confirmed malignant melanoma that is advanced or metastatic.
- Patients may have received up to 2 prior systemic chemotherapy regimens (including dacarbazine, and alternative dosing schedule of temozolomide). The last chemotherapy must have been at least 4 weeks prior to study drug administration.
- Prior radiation therapy will be allowed. Radiotherapy must have been completed at least 4 weeks prior to study drug administration.
- Patients may have received prior surgery. At least 4 weeks must have elapsed and patients must have recovered from all side effects associated with surgery.
- Patients with measurable disease. At least one bidimensionally measurable lesion with clearly defined margins documented by: medical photograph for skin and oral lesions, plain X-ray with at least one diameter 0.5 cm or greater, CT, MRI, or palpation with both diameters 2 cm or greater. A radiated bony lesion may not be considered an evaluable lesion, unless there is evidence of disease progression at that site prior to administration of study drug.
Key exclusion criteria (10 listed)
- Subjects who have brain metastases.
- More than 2 prior chemotherapy regimens for the treatment of advanced melanoma.
- Chemotherapy within four weeks prior to study drug administration.
- Radiation therapy to greater than or equal to 50% of the bone marrow. Patients must not have had prior radiotherapy to areas of measurable disease unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation.
- Insufficient recovery from all active toxicities of prior therapies.
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 was stopped early. Results are not available in the source record.
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 Malignant Melanoma, 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 10 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 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 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.
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.