A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00490451
First received: June 20, 2007
Last updated: December 9, 2010
Last verified: December 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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 ]
| Enrollment: | 101 |
| Study Start Date: | August 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: LY573636
LY573636 dose is dependent on patient's height, weight, and gender to target a specific Cmax. LY573636 is administered every 21 or 28 days until disease progression or other criteria for patient discontinuation are met.
Other Name: tasisulam
|
Detailed Description:
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).
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
Locations
| 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. | |
| Miami, Florida, United States, 33136 | |
| 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. | |
| Tampa, Florida, United States, 33624 | |
| 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, 60611 | |
| 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. | |
| Louisville, Kentucky, United States, 40202 | |
| 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. | |
| Albuquerque, New Mexico, United States, 87131 | |
| 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, 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. | |
| Portland, Oregon, United States, 97239 | |
| 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. | |
| 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. | |
| Nashville, Tennessee, United States, 37203 | |
| 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. | |
| Houston, Texas, United States, 77030 | |
| 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. | |
| 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. | |
| 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. | |
| 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:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00490451 History of Changes |
| Other Study ID Numbers: | 10408, H8K-MC-JZAD, H8K-MC-JZAD(a) |
| Study First Received: | June 20, 2007 |
| Last Updated: | December 9, 2010 |
| Health Authority: | United States: Food and Drug Administration Spain: Ministry of Health and Consumption Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013