A Study of Chemotherapy Treatment for Patients With Ovarian Cancer

March 17, 2018 updated by: Eli Lilly and Company

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rome, Italy, 00168
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Chicago, Illinois, United States, 60637
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • New York, New York, United States, 10021
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY573636
LY573636-sodium (LY573636) is administered every 28 days until disease progression or other criteria for participant discontinuation are met.
Drug: LY573636-sodium
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.
Other Names:
  • LY573636
  • tasisulam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Complete Response and Partial Response (Objective Response Rate)
Time Frame: Baseline to measured progressive disease up to 12.68 months
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
Time Frame: Baseline to measured progressive disease or death due to any cause up to 21.26 months
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)
Time Frame: Baseline to measured progressive disease up to 21.26 months
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
Time Frame: Predose up to 2 hours postdose in Cycles 1 and 2
Predose up to 2 hours postdose in Cycles 1 and 2
Overall Survival
Time Frame: First treatment to death due to any cause up to 42.91 months
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
Time Frame: Time of response to time of measured progressive disease up to 12.68 months
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
Time Frame: Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months
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)
Time Frame: First treatment dose up to 43.91 months
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

Other Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment
Time Frame: Study treatment discontinuation up to 30 days post study treatment discontinuation
Study treatment discontinuation up to 30 days post study treatment discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 26, 2007

First Submitted That Met QC Criteria

January 26, 2007

First Posted (Estimate)

January 30, 2007

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

March 17, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10410 (CTEP)
  • H8K-MC-JZAG (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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