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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

103

participants targeted

Target at P75+ for phase_2 ovarian-cancer

Timeline

Completed

Started Feb 2007

Typical duration for phase_2 ovarian-cancer

Geographic Reach

3 countries

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

First Submitted

Initial submission to the registry

January 26, 2007

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed

2 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed

6.3 years until next milestone

Results Posted

Study results publicly available

April 19, 2018

Completed

Last Updated

April 19, 2018

Status Verified

March 1, 2018

Enrollment Period

4 years

First QC Date

January 26, 2007

Results QC Date

March 17, 2018

Last Update Submit

March 17, 2018

Conditions

Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

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 Outcomes (7)

Progression Free Survival
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)
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
First treatment to death due to any cause up to 42.91 months
Duration of Response
Time of response to time of measured progressive disease up to 12.68 months
+2 more secondary outcomes

Other Outcomes (1)

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

Study Arms (1)

LY573636

EXPERIMENTAL

LY573636-sodium (LY573636) is administered every 28 days until disease progression or other criteria for participant discontinuation are met.

Drug: LY573636-sodium

Interventions

LY573636-sodiumDRUG

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.

Also known as: tasisulam, LY573636

LY573636

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (8)

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, 85258, United States

Location

Aurora, Colorado, 80045, United States

Location

Chicago, Illinois, 60637, United States

Location

New York, New York, 10021, United States

Location

Oklahoma City, Oklahoma, 73104, United States

Location

Brescia, 25123, Italy

Location

Rome, 00168, Italy

Location

Moscow, 115478, Russia

Location

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

N-((5-bromo-2-thienyl)sulfonyl)-2,4-dichlorobenzamide

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 26, 2007

First Posted

January 30, 2007

Study Start

February 1, 2007

Primary Completion

February 1, 2011

Study Completion

January 1, 2012

Last Updated

April 19, 2018

Results First Posted

April 19, 2018

Record last verified: 2018-03

Locations

IT(2)US(5)RU(1)

A Study of Chemotherapy Treatment for Patients With Ovarian Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Other Outcomes (1)

Study Arms (1)

LY573636

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Other Outcomes (1)

Study Arms (1)

LY573636

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations