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 |
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.
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).
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
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