STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma - Tabular View

Tracking Information
First Received Date ^ICMJE	June 9, 2004
Last Updated Date	December 3, 2008
Start Date ^ICMJE	May 2004
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00084214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma
Official Title ^ICMJE	A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma
Brief 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.
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Melanoma
Intervention ^ICMJE	Drug: STA-4783 Drug: Paclitaxel
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	103
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States
Expanded Access Status

Administrative Information
NCT ID ^ICMJE	NCT00084214
Responsible Party
Study ID Numbers ^ICMJE	4783-03
Study Sponsor ^ICMJE	Synta Pharmaceuticals, Corp.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Synta Pharmaceuticals, Corp.
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP