STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma - Full Text View

Sponsored by:	Synta Pharmaceuticals, Corp.
Information provided by:	Synta Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier:	NCT00084214

Purpose

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.

Condition	Intervention	Phase
Melanoma	Drug: STA-4783 Drug: Paclitaxel	Phase I Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma

Further study details as provided by Synta Pharmaceuticals, Corp.:

Estimated Enrollment:	103
Study Start Date:	May 2004

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084214

Show 28 Study Locations

Sponsors and Collaborators

Synta Pharmaceuticals, Corp.

More Information

Study ID Numbers:	4783-03
Study First Received:	June 9, 2004
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00084214
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals, Corp.:

metastatic
increased antitumor effect

Study placed in the following topic categories:

Neuroectodermal Tumors
Paclitaxel
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009