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A Study of Chemotherapy Treatment for Patients With Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00428610
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objective is to determine whether LY573636 is effective in treating platinum-resistant ovarian cancer. Patients will receive an intravenous infusion of study drug once every 28 days. CT scans and CA-125 tests will be done before the first dose and then after every other treatment.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Drug: LY573636 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of LY573636 as Treatment for Patients With Platinum-Resistant Ovarian Cancer
Study Start Date : February 2007
Primary Completion Date : February 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: LY573636 Drug: LY573636
LY573636 dose is dependent on patient's height, weight, and gender and is adjusted to target a specific Cmax based on patient laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for patient discontinuation are met.
Other Name: tasisulam


Outcome Measures

Primary Outcome Measures :
  1. Objective response rate (complete response and partial response) [ Time Frame: baseline to measured progressive disease ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: baseline to measured progressive disease ]
  2. Clinical Benefit Rate (complete response + partial response + stable disease) [ Time Frame: baseline to measured proressive disease ]
  3. Evaluate pharmacokinetics [ Time Frame: Cycle 1 - Cycle 6 ]
  4. overall survival [ Time Frame: baseline to date of death from any cause ]
  5. duration of response [ Time Frame: time of response to time of measured progressive disease ]
  6. duration of stable disease [ Time Frame: baseline to time of measured progressive disease ]
  7. Safety [ Time Frame: every cycle ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428610


Locations
United States, Arizona
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, United States, 85258
United States, Colorado
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, 80045
United States, Illinois
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, 60637
United States, New York
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, 10021
United States, Oklahoma
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, 73104
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, 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
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, Russian Federation, 115478
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00428610     History of Changes
Other Study ID Numbers: 10410
H8K-MC-JZAG ( Other Identifier: Eli Lilly and Company )
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases