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Sponsored by: |
Cambridge University Hospitals NHS Foundation Trust |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00563823 |
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: vatalanib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled |
Official Title: | A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma |
Estimated Enrollment: | 34 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed at 8 weeks and then periodically thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic cutaneous melanoma
PATIENT CHARACTERISTICS:
No concurrent severe and/or uncontrolled medical conditions that would compromise participation in the study, including any of the following:
No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib including, but not limited to, any of the following conditions:
PRIOR CONCURRENT THERAPY:
Prior radiotherapy allowed
No concurrent warfarin or other similar oral anticoagulants that are metabolized by the cytochrome p450 system
United Kingdom, England | |
Addenbrooke's Hospital | |
Cambridge, England, United Kingdom, CB2 2QQ | |
Leicester Royal Infirmary | |
Leicester, England, United Kingdom, LE1 5WW |
Study Chair: | Pippa Corrie, PhD, FRCP | Cambridge University Hospitals NHS Foundation Trust |
Study ID Numbers: | CDR0000576458, CRCA-CCTC-CAMEL02, EU-20787, EUDRACT-2005-004710-33, ISRCTN191981 |
Study First Received: | November 22, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00563823 History of Changes |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Nevus Protein Kinase Inhibitors |
Melanoma, Familial Recurrence Vatalanib Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Nerve Tissue Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Vatalanib Neuroectodermal Tumors Neoplasms Neoplasms, Germ Cell and Embryonal Nevi and Melanomas |