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Tracking Information | |||||
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First Received Date † | November 22, 2007 | ||||
Last Updated Date | October 8, 2008 | ||||
Start Date † | February 2006 | ||||
Current Primary Outcome Measures † |
Response rate as assessed by RECIST every 8 weeks [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00563823 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery | ||||
Official Title † | A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label, Uncontrolled | ||||
Condition † | Melanoma (Skin) | ||||
Intervention † | Drug: vatalanib | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 34 | ||||
Completion Date | |||||
Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00563823 | ||||
Responsible Party | |||||
Secondary IDs †† | CRCA-CCTC-CAMEL02, EU-20787, EUDRACT-2005-004710-33, ISRCTN191981 | ||||
Study Sponsor † | Cambridge University Hospitals NHS Foundation Trust | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | April 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |