A Phase 1 Dose-Escalation Study of LY2495655, an Anti-Myostatin Monoclonal Antibody, in Patients With Advanced Cancer
This study will consist of the following parts:
1. Dose Escalation - Cohorts of at least 3 participants will be treated with increasing
doses of LY2475655 until maximum tolerated dose (MTD) criteria are met in 1 of the 6
dose levels, or the 6th cohort is completed without meeting maximum tolerated dose
criteria.
2. Dose Confirmation - Up to 10 more participants will be enrolled to the MTD dose level,
or if it was not possible to define the MTD during dose escalation, all clinical and
bioanalytical data will be reviewed to select the recommended Phase 2 dose and an up to
10 additional participants will be enrolled to this dose level.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended dose for phase 2 studies
Baseline to study completion (approximately 51 months)
Yes
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)
Study Director
Eli Lilly and Company
United States: Food and Drug Administration
11207
NCT01524224
January 2008
August 2013
Name | Location |
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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. | Manhassaet, New York |
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. | Phoenix, Arizona 85012 |
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 |
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. | Seattle, Washington 98133 |