A Study of Avastin (Bevacizumab) and TACE Treatment in Patients With Liver Cancer.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576199
First received: December 18, 2007
Last updated: May 23, 2013
Last verified: May 2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 18, 2007 | ||||
| Last Updated Date | May 23, 2013 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Progression-free survival | ||||
| Change History | Complete list of historical versions of study NCT00576199 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Efficacy: Overall response rate, time to progression, disease control rate, overall survival, tumor necrosis rate. Safety: AEs, laboratory parameters. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of Avastin (Bevacizumab) and TACE Treatment in Patients With Liver Cancer. | ||||
| Official Title ICMJE | An Open Label Study of the Effect of Avastin Pre- and Post-transarterial Chemoembolisation (TACE) Treatment on Progression-free Survival in Patients With Localized Unresectable Hepatocellular Carcinoma. | ||||
| Brief Summary | This single arm, open label study will assess the efficacy and safety of Avastin treatment combined with transarterial chemoembolisation (TACE) in patients with localised unresectable liver cancer. Patients will be treated with TACE at 8 or 10 week intervals, and Avastin 5mg/kg iv will be administered 24-48 hours prior to first TACE and every 2 weeks thereafter. The anticipated time on study treatment is until disease progression or unmanageable toxicity, and the target sample size is <100 individuals. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Liver Cancer | ||||
| Intervention ICMJE | Drug: bevacizumab [Avastin]
5mg/kg iv every 2 weeks |
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| Study Arm (s) | Experimental: 1
Intervention: Drug: bevacizumab [Avastin] |
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| Publications * | Not Provided | ||||
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* 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 | ||||
| Enrollment ICMJE | 29 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | May 2011 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Hong Kong | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00576199 | ||||
| Other Study ID Numbers ICMJE | ML21358 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Hoffmann-La Roche | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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