Status:
COMPLETED
STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00084214
Start Date
May 1 2004
Last Update
March 6 2014
Active Locations (28)
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1
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
2
Univ Of Arkansas/Arkansas Research Center
Little Rock, Arkansas, United States, 72205-7101
3
Scripps Cancer Center
San Diego, California, United States, 92121
4
Northern California Melanoma Center
San Francisco, California, United States, 94109