STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synta Pharmaceuticals Corp.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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