Completed

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

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What is being tested

STA-4783

+ Paclitaxel

Drug
Who is being recruted

Neoplasms+13

+ Neoplasms by Histologic Type

+ Neoplasms by Site

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorSynta Pharmaceuticals Corp.
Last updated: March 6, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

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.

NCT00084214
Principal SponsorSynta Pharmaceuticals Corp.
Last updated: March 6, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

103 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplastic ProcessesPathologic ProcessesSkin DiseasesSkin NeoplasmsPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine TumorsMelanomaNeoplasm Metastasis

Criteria

8 inclusion criteria required to participate
At least 2 weeks have passed since last radiotherapy
At least 4 weeks have passed since last chemotherapy or immunotherapy
Clinical lab values within protocol parameters
ECOG performance status of greater than or equal to 2
Show More Criteria
8 exclusion criteria prevent from participating
Female patients of childbearing potential not using or not willing to use effective contraception
Female patients pregnant or lactating
History of severe hypersensitivity reactions to taxanes
Presence of a clinically significant and uncontrolled infection
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 28 locations

Genesis Cancer Center

Hot Springs, United StatesOpen Genesis Cancer Center in Google Maps

Univ Of Arkansas/Arkansas Research Center

Little Rock, United States

Scripps Cancer Center

San Diego, United States

Northern California Melanoma Center

San Francisco, United States
Completed28 Study Centers