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A Study of Tasisulam in Treating Participants With Malignant Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Tasisulam in Treating Participants With Malignant Melanoma

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

NCT00383292•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (13)

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.

Los Angeles, California, United States

Aurora, Colorado, United States

Lakeland, Florida, United States

Indianapolis, Indiana, United States

Rochester, Minnesota, United States

Albuquerque, New Mexico, United States

Pittsburgh, Pennsylvania, United States

Memphis, Tennessee, United States

Coffs Harbour, New South Wales, Australia

Wollongong, New South Wales, Australia

Key Dates

Start Date

November 1, 2006

Primary Completion Date

September 1, 2011

Completion Date

July 1, 2015

Last Updated

June 6, 2018

Enrollment

130

ACTUAL participants

Conditions

Metastatic Melanoma

Interventions

tasisulam

DRUG

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

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RECRUITINGNA

Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma

NCT07112170

Metastatic MelanomaOligoProgressive Metastatic Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Tasisulam in Treating Participants With Malignant Melanoma

Inclusion Criteria

Exclusion Criteria

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