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STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma

NCT00084214•Synta Pharmaceuticals Corp.

Summary

This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients.

Detailed Description

STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•M or F 18 or older with histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
•ECOG performance status of greater than or equal to 2
•Measurable disease per RECIST criteria
•Received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy regimens are allowed)
•At least 4 weeks have passed since last chemotherapy or immunotherapy
•At least 2 weeks have passed since last radiotherapy.
•Life expectancy of greater than 12 weeks
•Clinical lab values within protocol parameters

Exclusion Criteria

•Female patients pregnant or lactating
•Female patients of childbearing potential not using or not willing to use effective contraception
•Presence of a second malignancy other than nonmelanoma skin cancer
•Presence of a clinically significant and uncontrolled infection
•Presence of clinically significant arrythmias
•Presence of serious concurrent illness or other conditions that do not permit adequate follow-up and compliance with protocol
•History of severe hypersensitivity reactions to taxanes
•Use of any investigational agents within 4 weeks prior to the first dose of study drug

Locations (28)

Genesis Cancer Center

Hot Springs, Arkansas, United States

Univ Of Arkansas/Arkansas Research Center

Little Rock, Arkansas, United States

Scripps Cancer Center

San Diego, California, United States

Northern California Melanoma Center

San Francisco, California, United States

Cancer Institute Medical Group, Inc

Santa Monica, California, United States

Anschutz Cancer Pavillion - Univ Of Colorado

Aurora, Colorado, United States

Hematology Oncology P.C.

Stamford, Connecticut, United States

Medical Oncology and Hematology, P.C.

Waterbury, Connecticut, United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

Research Institute Hawaii Pacific Health

Honolulu, Hawaii, United States

Key Dates

Start Date

May 1, 2004

Last Updated

March 6, 2014

Enrollment

103

Estimated participants

Conditions

Melanoma

Interventions

STA-4783

DRUG

Paclitaxel

DRUG

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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: March 6, 2014Data 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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STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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