A Study of Chemotherapy Treatment for Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428610
• Other study ID #: 10410
• Secondary ID: H8K-MC-JZAG
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2007
• Last updated: March 17, 2018
• Start date: February 2007
• Est. completion date: January 2012

Study information

• Verified date: March 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: January 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Cancer

Intervention

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.

Locations

Country	Name	City	State
Italy	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.	Brescia
Italy	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
Russian Federation	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.	Moscow
United States	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.	Aurora	Colorado
United States	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.	Chicago	Illinois
United States	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
United States	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 City	Oklahoma
United States	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.	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Italy,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment		Study treatment discontinuation up to 30 days post study treatment discontinuation
Primary	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	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
Secondary	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
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY573636		Predose up to 2 hours postdose in Cycles 1 and 2
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Lilly Clinical Trial Registry