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A Phase 2 Study of LY573636-Sodium Administered as Second-line or Third-line Treatment in Patients With Unresectable or Metastatic Soft Tissue Sarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma, Soft Tissue

Thank you

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