A Study of LY573636 in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00992225
First received: October 7, 2009
Last updated: August 9, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: LY573636
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Evaluation of a Once Every 28 Days Dosing Regimen for LY573636-sodium in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Overall Responders [Complete Response (CR) + Partial Response (PR)] [ Time Frame: Baseline to measured progressive disease or death from any cause (assessed every other cycle during study therapy, or every 2 months during post-therapy until disease progression or death) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Baseline to measured progressive disease or death from any cause (assessed every other cycle during study therapy, or every 2 months during post-therapy until disease progression or death) ] [ Designated as safety issue: No ]
  • Number of Patients Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)] [ Time Frame: Baseline to measured progressive disease or death from any cause (assessed every other cycle during study therapy, or every 2 months during post-therapy until disease progression or death) ] [ Designated as safety issue: No ]
  • Duration of Overall Response [ Time Frame: Time of response to progressive disease or death (assessed every other cycle during study therapy, or every 2 months during post-therapy until disease progression, or death) ] [ Designated as safety issue: No ]
  • Duration of Stable Disease [ Time Frame: Time from documented Stable Disease (SD) to first date of progressive disease or death from any cause (assessed every cycle during study therapy, or every 2 months during post-therapy until disease progression, or death) ] [ Designated as safety issue: No ]
  • Pharmacokinetics AUC [ Time Frame: Cycle 1 (day 1, days 4-8, days 15-21 of a 28 day cycle), Cycle 2 (day 1, days 4-8, days 15-21 of a 28 day cycle), Cycles 3-6 (day 1 of 28 day cycle) ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics Cmax [ Time Frame: Cycle 1 (day 1, days 4-8, days 15-21 of a 28 day cycle), Cycle 2 (day 1, days 4-8, days 15-21 of a 28 day cycle), Cycles 3-6 (day 1 of 28 day cycle) ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY573636 Drug: LY573636
Dose is adjusted to target a specific Cmax based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met
Other Name: tasisulam

Detailed Description:

Patient will receive a 2-hour intravenous infusion of study drug (LY573636) once every 28 days. Radiologic 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 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:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992225

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.
Tampa, Florida, United States, 33612
United States, Indiana
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, United States, 46202
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, 97225
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
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.
Temple, Texas, United States, 76508
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

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00992225     History of Changes
Other Study ID Numbers: 12265, H8K-MC-JZAL
Study First Received: October 7, 2009
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014