A Study of LY573636 in Patients With Metastatic Breast Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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
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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013