Phase 2 Evaluation of a Once Every 28 Days Dosing Regimen for LY573636-sodium in Patients With Metastatic Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
Phase 2 Evaluation of a Once Every 28 Days Dosing Regimen for LY573636-sodium in Patients With Metastatic Breast Cancer
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).
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Overall Responders [Complete Response (CR) + Partial Response (PR)]
Outcome 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)
Safety Issue:
No
Principal Investigator
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)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
12265
NCT ID:
NCT00992225
Start Date:
September 2009
Completion Date:
April 2011
Related Keywords:
- Breast Cancer
- Metastatic
- Breast Neoplasms
Name | 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. | Jacksonville, Florida 32256 |
| 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 46227 |
| 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. | Eugene, Oregon 97401 |
| 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 |
| 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. | Bedford, Texas 76022 |
