A Study of LY573636-sodium in Patients With Metastatic Breast Cancer

NCT00992225 | Completed Phase 2 Results

• 2 other identifiers: 12265H8K-MC-JZAL
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 5

Brief Summary

The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636-sodium for metastatic breast cancer.

Conditions

Breast Cancer

Keywords

Metastatic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Objective Overall Response

  Objective overall response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. It is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.

  Baseline to measured progressive disease or death from any cause up to 12 months

Secondary Outcomes (6)

• Progression-free Survival

  Baseline to measured progressive disease or death from any cause up to 12 months

• Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)]

  Baseline to measured progressive disease or death from any cause up to 12 months

• Duration of Overall Response

  Time of response to progressive disease or death up to 12 months

• Duration of Stable Disease

  Time from documented Stable Disease (SD) to first date of progressive disease or death from any cause up to 12 months

• The Percentage of Participants With Exposures in the Target Range

  After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)

Study Arms (1)

LY573636-sodium

EXPERIMENTAL

Drug: LY573636-sodium

Interventions

LY573636-sodium DRUG

Dose is adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met

Also known as: tasisulam

LY573636-sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer.
• Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. Patients who have received whole-brain radiation must wait 90 days.

You may not qualify if:

• Serious pre-existing medical condition.
• Have active central nervous system or leptomeningeal metastasis.
• Current hematologic malignancies, acute or chronic leukemia.
• Receiving Warfarin (Coumadin).
• Have a history of radiation therapy involving more than 25% of the bone marrow.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

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, 33612, United States

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.

Indianapolis, Indiana, 46202, United States

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.

Portland, Oregon, 97225, United States

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.

Memphis, Tennessee, 38138, United States

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.

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

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

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

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: October 7, 2009
• First Posted: October 9, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 17, 2018
• Results First Posted: July 17, 2018

Record last verified: 2018-06

Locations

US (5)