Phase 2
N=103
A Study of Chemotherapy Treatment for Patients With Ovarian Cancer
Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00428610 ↗Enrolled (actual)
103
Serious AEs
39.8%
Results posted
Apr 2018
Primary outcome: Primary: Percentage of Participants With Complete Response and Partial Response (Objective Response Rate) — 7.5; 0; 3.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY573636-sodium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response and Partial Response (Objective Response Rate) |
7.5; 0; 3.1 | — |
| SECONDARY Progression Free Survival |
1.87; 2.40; 2.10 | — |
| SECONDARY Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate) |
45.3; 61.1; 34.4 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 |
368.4; 324.1; 340.9; 323.0; 326.1; 320.7 | — |
| SECONDARY Overall Survival |
13.08; 10.09; 11.63 | — |
| SECONDARY Duration of Response |
5.03; 12.68 | — |
| SECONDARY Duration of Stable Disease |
3.71; 3.27; 3.78 | — |
| SECONDARY Number of Participants With Adverse Events (Safety) |
21; 5; 15; 47; 18; 30 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00428610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.