STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00084214
First received: June 9, 2004
Last updated: March 5, 2014
Last verified: December 2008
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 28 Study Locations
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

No publications provided

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00084214     History of Changes
Other Study ID Numbers: 4783-03
Study First Received: June 9, 2004
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:
metastatic
increased antitumor effect

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014