A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00490451

Purpose

The primary purpose of the study is to estimate the time from the first dose of LY573636 to the date your physician determines that your disease has progressed or worsened.

Condition	Intervention	Phase
Sarcoma, Soft Tissue	Drug: LY573636	Phase II

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: LY-573636

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of LY573636-Sodium Administered as Second-Line or Third-Line Treatment in Patients With Unresectable or Metastatic Soft Tissue Sarcoma

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Progression-free survival. [ Time Frame: Baseline to measured progressive disease. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response rate (complete response + partial response). [ Time Frame: Baseline to measured progressive disease. ] [ Designated as safety issue: No ]
Clinical benefit rate (complete response + partial response + stable disease). [ Time Frame: Baseline to measured progressive disease. ] [ Designated as safety issue: No ]
Pharmacokinetics. [ Time Frame: Before and after each dose (Cycles 1 through 6). ] [ Designated as safety issue: No ]
Overall survival time. [ Time Frame: Baseline to date of death from any cause. ] [ Designated as safety issue: Yes ]
Duration of overall objective response. [ Time Frame: From time of response to time of measured progressive disease. ] [ Designated as safety issue: No ]
Duration of stable disease. [ Time Frame: Time from stable disease to time of measured progressive disease. ] [ Designated as safety issue: No ]
Safety [ Time Frame: Every cycle. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: LY573636 A loading dose to target 360 micrograms/mL Cmax followed by a lower chronic dose (which is 90% of the loading dose) to maintain the Cmax within the target range will be administered intravenously every 21 days until disease progression or unacceptable toxicity.

Detailed Description:

Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 21 days. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 42 days (every other cycle).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of soft tissue sarcoma that is unresectable or metastatic
Have received one or two (but no more than two) prior treatment regimens for metastatic soft tissue sarcoma, one of which must have included doxorubicin (adriamycin).
Must have stopped all previous treatments for cancer, including chemotherapy, radiation therapy or other investigational treatments for cancer for at least 30 days

Exclusion Criteria:

Patients with primary bone sarcoma (e.g. osteosarcoma, Ewing's sarcoma, chondrosarcoma), gastrointestinal stromal tumor (GIST) and Kaposi's sarcoma
Serious pre-existing medical problems (as determined by your doctor)
Have received more that two previous systemic treatment regimens for unresectable or metastatic soft tissue sarcoma
Have a second primary cancer (unless cancer-free for more than 2 years)
Active treatment with Warfarin (Coumadin)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490451

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Locations

United States, California
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.	Recruiting
Duarte, California, United States, 91010
Contact: Eli Lilly
United States, Florida
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.	Recruiting
Miami, Florida, United States, 33136
Contact: Eli Lilly
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.	Recruiting
Tampa, Florida, United States, 33624
Contact: Eli Lilly
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.	Recruiting
Chicago, Illinois, United States, 60611
Contact: Eli Lilly
United States, Kentucky
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.	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Eli Lilly
United States, Michigan
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.	Recruiting
Detroit, Michigan, United States, 48201
Contact: Eli Lilly
United States, New Mexico
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.	Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Eli Lilly
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.	Recruiting
New York, New York, United States, 10021
Contact: Eli Lilly
United States, Oregon
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.	Recruiting
Portland, Oregon, United States, 97239
Contact: Eli Lilly
United States, Tennessee
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.	Active, not recruiting
Memphis, Tennessee, United States, 38138
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.	Recruiting
Nashville, Tennessee, United States, 37203
Contact: Eli Lilly
United States, Texas
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.	Recruiting
Houston, Texas, United States, 77030
Contact: Eli Lilly
United States, Wisconsin
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.	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Eli Lilly
Argentina
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.	Active, not recruiting
Buenos Aires, Argentina, C1280AEB
Spain
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.	Active, not recruiting
Barcelona, Spain, 08907
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.	Active, not recruiting
Madrid, Spain, 28040

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly and Company ( Chief Medical Officer )
Study ID Numbers:	10408, H8K-MC-JZAD, H8K-MC-JZAD(a)
Study First Received:	June 20, 2007
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00490451 History of Changes
Health Authority:	United States: Food and Drug Administration; Spain: Ministry of Health and Consumption; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Benzocaine
Sarcoma

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Sarcoma

ClinicalTrials.gov processed this record on May 07, 2009