Brief Summary

The primary purpose of the study is to estimate the time from the first dose of LY573636-sodium (hereafter referred to as LY573636) to the date your physician determines that your disease has progressed or worsened.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

101

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Aug 2007

Geographic Reach

3 countries

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

June 20, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed

1 month until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed

8.3 years until next milestone

Results Posted

Study results publicly available

May 2, 2018

Completed

Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

2.5 years

First QC Date

June 20, 2007

Results QC Date

March 17, 2018

Last Update Submit

September 6, 2019

Conditions

Sarcoma, Soft Tissue

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival
Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
First treatment dose to measured progressive disease or death from any cause up to 15.57 months

Secondary Outcomes (7)

Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)
First treatment dose to measured progressive disease or death due to any cause up to 15.57 months
Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)
First treatment dose to measured progressive disease or death due to any cause up to 15.57 months
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Predose up to 2 hours postdose in Cycles 1 and 2 (21- or 28-day cycle)
Overall Survival Time
First treatment dose to death due to any cause up to 26.51 months
Duration of Overall Objective Response
Time of response to progressive disease or death up to 15.57 months
+2 more secondary outcomes

Study Arms (1)

LY573636

EXPERIMENTAL

Drug: LY573636-sodium

Interventions

LY573636-sodiumDRUG

LY573636 dose is dependent on patient's height, weight, and gender to target a specific maximum concentration (Cmax). LY573636 is administered intravenously every 21 or 28 days until disease progression or other criteria for patient discontinuation are met.

Also known as: Tasisulam

LY573636

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Participants with primary bone sarcoma (for example 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 than 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (13)

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, 33136, United States

Location

Tampa, Florida, 33624, United States

Location

Chicago, Illinois, 60611, United States

Location

Louisville, Kentucky, 40202, United States

Location

Albuquerque, New Mexico, 87131, United States

Location

New York, New York, 10021, United States

Location

Portland, Oregon, 97239, United States

Location

Memphis, Tennessee, 38138, United States

Location

Nashville, Tennessee, 37203, United States

Location

Houston, Texas, 77030, United States

Location

Buenos Aires, C1280AEB, Argentina

Location

Barcelona, 08907, Spain

Location

Madrid, 28040, Spain

Location

Related Publications (1)

Ryan CW, Matias C, Agulnik M, Lopez-Pousa A, Williams C, de Alwis DP, Kaiser C, Miller MA, Ermisch S, Ilaria R Jr, Keohan ML. A phase II study of tasisulam sodium (LY573636 sodium) as second-line or third-line treatment for patients with unresectable or metastatic soft tissue sarcoma. Invest New Drugs. 2013 Feb;31(1):145-51. doi: 10.1007/s10637-012-9819-5. Epub 2012 Apr 27.
PMID: 22539091DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

N-((5-bromo-2-thienyl)sulfonyl)-2,4-dichlorobenzamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 22, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

September 18, 2019

Results First Posted

May 2, 2018

Record last verified: 2019-09

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US(10)AR(1)ES(2)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

LY573636

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

LY573636

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations