A Phase 2 Study of LY573636 Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle as Second-Line Treatment in Patients With Unresectable or Metastatic Melanoma
18 Years
N/A
Both
Metastatic Melanoma
Trial Information
A Phase 2 Study of LY573636 Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle as Second-Line Treatment in Patients With Unresectable or Metastatic Melanoma
Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 28
days. Radiological 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:
- Diagnosis of malignant melanoma that is unresectable or metastatic (Stage III or IV)
- Have received 1 previous systemic treatment regimen for unresectable or metastatic
melanoma. An immunotherapy or antibody-based regimen (including vaccination-based
treatments) is not counted as a prior treatment regimen for determining study
eligibility, unless it was combined with a chemotherapeutic or targeted anti-cancer
drug.
- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, immunotherapy, or other investigational therapy for at least 30 days
Exclusion Criteria:
- Serious pre-existing medical conditions
- Have received two or more previous treatment regimens for unresectable or metastatic
melanoma
- Have a second primary cancer (unless disease-free to more than 2 years)
- Active treatment with Warfarin (Coumadin)
- Primary ocular or mucosal melanoma
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:
Objective response rate (complete response + partial response).
Outcome Time Frame:
Baseline to measured progressive disease.
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:
10409
NCT ID:
NCT00383292
Start Date:
November 2006
Completion Date:
July 2013
Related Keywords:
- Metastatic Melanoma
- Melanoma
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. | Denver, Colorado |
| 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. | Greenbrae, California 94904 |
| 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. | Minneapolis, Minnesota 55404 |
| 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. | Dunmore, Pennsylvania 18512 |
| 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. | Albuquerque, New Mexico 87106 |
