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NCT01416389 · ClinicalTrials.gov registry record · Phase 2
A Study of LY2523355 in Participants With Breast Cancer
A Phase 2 study of Metastatic Breast Cancer, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 12
- Study locations
NCT01416389: Completed Phase 2 study of Metastatic Breast Cancer, sponsored by Eli Lilly and Company.
NCT01416389 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by Eli Lilly and Company. The registered enrollment target is 39 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (81% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01416389, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response.
Primary Outcome
The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment.
Conditions Studied
Interventions
- DRUG pegfilgrastim
- DRUG filgrastim
- DRUG ixabepilone
- DRUG LY2523355
Study Locations (12)
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. - Fort Myers
- 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. - Pensacola
Ohio
- 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. - Cincinnati
- 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. - Toledo
South Carolina
- 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. - Columbia
- 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. - Spartanburg
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. - Chattanooga
- 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. - Nashville
Georgia
- 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. - Gainesville
Maryland
- 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. - Bethesda
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. - Fort Worth
Virginia
- 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. - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT01416389 record still lists
NCT01416389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which pegfilgrastim is the first listed.
NCT01416389 lists 12 locations in 8 states (Florida, Ohio, South Carolina).
Frequently Asked Questions
What is clinical trial NCT01416389 about?
NCT01416389 is a clinical study titled "A Study of LY2523355 in Participants With Breast Cancer". The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response.
What is the current status of trial NCT01416389?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2011-08. Estimated completion is 2013-09.
What conditions does trial NCT01416389 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT01416389?
The interventions under investigation include: pegfilgrastim (DRUG), filgrastim (DRUG), ixabepilone (DRUG), LY2523355 (DRUG).
Who is sponsoring clinical trial NCT01416389?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01416389 being conducted?
This trial has 12 study locations across Florida, Georgia, Maryland, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01416389's enrollment target sits among peer trials
39 96th of 139 higher than 44 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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