Brief Title
A Study of Chemotherapy Treatment for Patients With Ovarian Cancer
Official Title
A Phase 2 Study of LY573636-Sodium as Treatment for Patients With Platinum-Resistant Ovarian Cancer
Brief Summary
The primary objective is to determine whether LY573636-sodium (hereafter referred to as
LY573636) is effective in treating platinum-resistant ovarian cancer. Patients will receive
an intravenous infusion of study drug once every 28 days. Computed tomography (CT) scans and
CA-125 tests will be done before the first dose and then after every other treatment.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Percentage of Participants With Complete Response and Partial Response (Objective Response Rate)
Secondary Outcome
Progression Free Survival
Condition
Ovarian Cancer
Intervention
LY573636-sodium
Study Arms / Comparison Groups
LY573636
Description: LY573636-sodium (LY573636) is administered every 28 days until disease progression or other criteria for participant discontinuation are met.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
103
Start Date
February 2007
Completion Date
January 2012
Primary Completion Date
February 2011
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal
cancer
- At least 18 years old
- Have received at least one but no more than 2 systemic treatment regimens containing
platinum (does not include regimens received before surgery for this cancer)
- Have platinum-resistant disease
Exclusion Criteria:
- Have received more than 2 systemic treatment regimens for platinum-resistant disease
- Serious pre-existing medical conditions
- Actively receiving warfarin (Coumadin) for treatment of venous thrombosis or other
prothrombotic conditions
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT00428610
Organization ID
10410
Secondary IDs
H8K-MC-JZAG
Responsible Party
Sponsor
Study Sponsor
Eli Lilly and Company
Study Sponsor
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Eli Lilly and Company
Verification Date
March 2018