A Phase 2 Study of LY573636-Sodium Administered as Second-line or Third-line Treatment in Patients With Unresectable or Metastatic Soft Tissue Sarcoma
18 Years
N/A
Both
Sarcoma, Soft Tissue
Trial Information
A Phase 2 Study of LY573636-Sodium Administered as Second-line or Third-line Treatment in Patients With Unresectable or Metastatic Soft Tissue Sarcoma
Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 21
days or 28 days depending on their target dose. 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 or 56 days (every other cycle).
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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival.
Outcome Time Frame:
Baseline to measured progressive disease.
Safety Issue:
No
Principal Investigator
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)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
10408
NCT ID:
NCT00490451
Start Date:
August 2007
Completion Date:
February 2010
Related Keywords:
- Sarcoma, Soft Tissue
- Sarcoma
Name | Location |
|---|---|
| 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. | Manhassaet, 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. | Jacksonville, Florida 32256 |
| 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 60674 |
| 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. | Eugene, Oregon 97401 |
| 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. | Memphis, Tennessee 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. | Bedford, Texas 76022 |
| 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. | Albuquerque, New Mexico 87106 |
| 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. | Lexington, Kentucky 40536 |
