- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00060710
CP-461 in the Treatment of Patients With Advanced Melanoma
October 14, 2011 updated by: Astellas Pharma Inc
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.
Study Overview
Study Type
Interventional
Enrollment
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia Presbyterian Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
May 9, 2003
First Submitted That Met QC Criteria
May 12, 2003
First Posted (Estimate)
May 13, 2003
Study Record Updates
Last Update Posted (Estimate)
October 17, 2011
Last Update Submitted That Met QC Criteria
October 14, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSI-461-013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malignant Melanoma
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National Cancer Institute (NCI)TerminatedRecurrent Melanoma | Stage IV Melanoma | Acral Lentiginous Malignant Melanoma | Lentigo Maligna Malignant Melanoma | Nodular Malignant Melanoma | Solar Radiation-related Skin Melanoma | Superficial Spreading Malignant MelanomaUnited States
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Grupo Español Multidisciplinar de MelanomaGlaxoSmithKlineCompletedMalignant Melanoma Stage IV | Malignant Melanoma Stage IIIcSpain
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Centre Hospitalier Universitaire de NiceUnknownMalignant Melanoma Stage III | Malignant Melanoma Stage IV
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Hoffmann-La RocheCompletedMalignant Melanoma, CancerHungary
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Hoffmann-La RocheCompletedMalignant Melanoma, NeoplasmsUnited States, South Africa, Croatia, Brazil, Egypt
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Lynn E. Spitler, MDGenentech, Inc.; Celgene CorporationCompletedMetastatic Malignant MelanomaUnited States
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National Cancer Institute (NCI)GlaxoSmithKline; Novartis PharmaceuticalsActive, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Metastatic Melanoma | Stage IV Cutaneous Melanoma AJCC v6 and v7 | Locally Advanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Locally Advanced Melanoma | Metastatic Malignant Solid Neoplasm | Stage IIIC Cutaneous Melanoma AJCC v7 | Unresectable...United States
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Hoffmann-La RocheCompletedMalignant Melanoma, NeoplasmsKorea, Republic of, Brazil, United States, Canada, Cyprus
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Hoffmann-La RocheCompletedMalignant Melanoma, NeoplasmsSpain, New Zealand, Hungary, Serbia, Germany, Portugal, Netherlands, Greece, Australia
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Steinar AamdalTerminatedMetastatic Malignant MelanomaNorway
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