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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma

Thank you

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