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CP-461 in the Treatment of Patients With Advanced Melanoma

This study has been terminated.
Sponsor:
Collaborators:
Cell Pathways
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00060710
First received: May 9, 2003
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Drug: CP-461
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of CP-461 in the Treatment of Patients With Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment: 35
Study Start Date: January 2003
Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060710

Locations
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Astellas Pharma Inc
Cell Pathways
OSI Pharmaceuticals
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00060710     History of Changes
Other Study ID Numbers: OSI-461-013
Study First Received: May 9, 2003
Last Updated: October 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 27, 2014