A Study of Chemotherapy Treatment for Patients With Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Study of LY573636-Sodium as Treatment for Patients With Platinum-Resistant Ovarian Cancer

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Intervention / Treatment
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* Drug: LY573636-sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY573636<br>LY573636-sodium (LY573636) is administered every 28 days until disease progression or other criteria for participant discontinuation are met. | Drug: LY573636-sodium<br>* LY573636 dose is dependent on participant's height, weight, and gender and is adjusted to target a specific maximum concentration (Cmax) based on participant laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for participant discontinuation are met.<br>* Other names: LY573636;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Complete Response and Partial Response (Objective Response Rate) | Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | Baseline to measured progressive disease up to 12.68 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | Baseline to measured progressive disease or death due to any cause up to 21.26 months | 
| Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate) | Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated multiplied by 100. | Baseline to measured progressive disease up to 21.26 months | 
| Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 |  | Predose up to 2 hours postdose in Cycles 1 and 2 | 
| Overall Survival | Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact. | First treatment to death due to any cause up to 42.91 months | 
| Duration of Response | The duration of response (complete response [CR] or partial response [PR]) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. | Time of response to time of measured progressive disease up to 12.68 months | 
| Duration of Stable Disease | Duration of stable disease is defined from date of documented stable disease (SD) or better to first date of progressive disease or death from any cause (assessed every cycle during study therapy, or every 2 months during post-therapy until disease progression or death). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months | 
| Number of Participants With Adverse Events (Safety) | Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. | First treatment dose up to 43.91 months |