Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery
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ClinicalTrials.gov Identifier: NCT00563823 |
Recruitment Status
:
Completed
First Posted
: November 26, 2007
Last Update Posted
: August 2, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | November 22, 2007 | |||
First Posted Date ICMJE | November 26, 2007 | |||
Last Update Posted Date | August 2, 2013 | |||
Study Start Date ICMJE | February 2006 | |||
Actual Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Response rate as assessed by RECIST every 8 weeks | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00563823 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery | |||
Official Title ICMJE | 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 Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Melanoma (Skin) | |||
Intervention ICMJE | Drug: vatalanib | |||
Study Arms | Not Provided | |||
Publications * | Cook N, Basu B, Biswas S, Kareclas P, Mann C, Palmer C, Thomas A, Nicholson S, Morgan B, Lomas D, Sirohi B, Mander AP, Middleton M, Corrie PG. A phase 2 study of vatalanib in metastatic melanoma patients. Eur J Cancer. 2010 Oct;46(15):2671-3. doi: 10.1016/j.ejca.2010.07.014. Epub 2010 Aug 25. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
34 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | October 2010 | |||
Actual Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00563823 | |||
Other Study ID Numbers ICMJE | CRCA-CCTC-CAMEL02 CDR0000576458 ( Registry Identifier: PDQ (Physician Data Query) ) EU-20787 EUDRACT-2005-004710-33 CCLG-Camel-02 ISRCTN00191981 ( Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register) ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Cambridge University Hospitals NHS Foundation Trust | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||
Verification Date | April 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |