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Tracking Information | |||||||||
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First Received Date ICMJE | August 9, 2011 | ||||||||
Last Updated Date | August 30, 2012 | ||||||||
Start Date ICMJE | September 2011 | ||||||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
progression free survival [ Time Frame: 4 month ] [ Designated as safety issue: No ] To determine 4month progression-free survival of TKI258 (Dovitinib) when administered as monotherapy in patients with unresectable adenoid cystic carcinoma |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01417143 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 | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Dovitinib in Adenoid Cystic Carcinoma | ||||||||
Official Title ICMJE | Phase II Study of TKI258 (Dovitinib) Monotherapy in Patients With Unresectable Adenoid Cystic Carcinoma | ||||||||
Brief Summary | The purpose of this phase II study of TKI258 (Dovitinib) in adenoid cystic carcinoma is to evaluate the efficacy of TKI258 (Dovitinib). |
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Detailed Description | open, uncontrolled, multi-center, phase II study |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Adenoid Cystic Carcinoma | ||||||||
Intervention ICMJE | Drug: TKI258 (Dovitinib):
TKI258 (Dovitinib): 500 mg daily po medication with 5 days on/2 days off schedule. TKI258 (Dovitinib) will be provided by Norvatis for the study purpose. One cycle consists of 4 weeks |
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Study Arms | Experimental: TKI258 (Dovitinib)
TKI258 (Dovitinib): 500 mg daily po medication with 5 days on/2 days off schedule. TKI258 (Dovitinib) will be provided by Norvatis for the study purpose. One cycle consists of 4 weeks
Intervention: Drug: TKI258 (Dovitinib): |
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Publications * | |||||||||
* 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 | Recruiting | ||||||||
Estimated Enrollment ICMJE | 33 | ||||||||
Estimated Completion Date | September 2013 | ||||||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Korea, Republic of | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01417143 | ||||||||
Other Study ID Numbers ICMJE | H-1012-047-344 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | Yung-Jue Bang, Seoul National University Hospital | ||||||||
Study Sponsor ICMJE | Seoul National University Hospital | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE | |||||||||
Information Provided By | Seoul National University Hospital | ||||||||
Verification Date | August 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |