Clinical trial NCT00992225: A Study of LY573636-sodium in Patients With Metastatic Breast Cancer
Official title: Phase 2 Evaluation of a Once Every 28 Days Dosing Regimen for LY573636-sodium in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Metastatic
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Patient will receive a 2-hour intravenous infusion of study drug (LY573636-sodium) 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 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.

Primary outcomes:
measure: Percentage of Participants With an Objective Overall Response
timeFrame: Baseline to measured progressive disease or death from any cause up to 12 months
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Baseline to measured progressive disease or death from any cause up to 12 months
measure: Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)]
timeFrame: Baseline to measured progressive disease or death from any cause up to 12 months
measure: Duration of Overall Response
timeFrame: Time of response to progressive disease or death up to 12 months
measure: Duration of Stable Disease
timeFrame: Time from documented Stable Disease (SD) to first date of progressive disease or death from any cause up to 12 months
measure: The Percentage of Participants With Exposures in the Target Range
timeFrame: After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)
measure: Maximum Concentration (Cmax)
timeFrame: After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)]
Other outcomes:
Locations:
city: Tampa
country: United States
facility: 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.
state: Florida
city: Indianapolis
country: United States
facility: 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.
state: Indiana
city: Portland
country: United States
facility: 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.
state: Oregon
city: Memphis
country: United States
facility: 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.
state: Tennessee
city: Temple
country: United States
facility: 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.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: