A Study of Chemotherapy Treatment for Patients With Ovarian Cancer
Tracking Information
Start Date ICMJE | February 2007 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 21, 2007) | Objective response rate (complete response and partial response) [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: January 26, 2007) | Objective response rate (complete response and partial response) |
Change History | Complete list of historical versions of study NCT00428610 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 21, 2007) |
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Original Secondary Outcome Measures ICMJE (submitted: January 26, 2007) |
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Descriptive Information
Brief Title ICMJE | A Study of Chemotherapy Treatment for Patients With Ovarian Cancer |
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Official Title ICMJE | A Phase 2 Study of LY573636 as Treatment for Patients With Platinum-Resistant Ovarian Cancer |
Brief Summary | The primary objective is to determine whether LY573636 is effective in treating platinum-resistant ovarian cancer. Patients will receive an intravenous infusion of study drug once every 28 days. CT scans and CA-125 tests will be done before the first dose and then after every other treatment. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE | Drug: LY573636 LY573636 dose is dependent on patient's height, weight, and gender and is adjusted to target a specific Cmax based on patient laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for patient discontinuation are met. |
Study Arms / Comparison Groups | LY573636: Experimental Intervention: Drug: LY573636 |
Recruitment Information
Estimated Enrollment ICMJE | 100 | ||||
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Estimated Completion Date | March 2011 | ||||
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Italy, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00428610 | ||||
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Responsible Party | Chief Medical Officer, Eli Lilly and Company | ||||
Study ID Numbers ICMJE | 10410, H8K-MC-JZAG | ||||
Study Sponsor ICMJE | Eli Lilly and Company | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Eli Lilly and Company |
Source: http://clinicaltrials.gov/