A Study of Tasisulam in Treating Participants With Malignant Melanoma



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/8/2018
Start Date:November 2006
End Date:July 2015

Use our guide to learn which trials are right for you!

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

The primary purpose of this study is to determine the objective response rate (complete and
partial response) for participants who receive tasisulam after one prior systemic treatment
for unresectable or metastatic melanoma.

Participants will receive a 2-hour intravenous infusion of study drug (tasisulam) once every
28 days. Radiological imaging scans will be performed before the first dose of study drug and
then after every other treatment. Participants 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
We found this trial at
9
sites
?
mi
from
Coffs Harbour,
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Rochester, MN
Click here to add this to my saved trials