A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas

Soft Tissue Sarcoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087997
• Other study ID #: 4783-04
• Status: Completed
• Phase: Phase 2
• First received: July 19, 2004
• Last updated: June 19, 2006
• Start date: July 2004
• Est. completion date: October 2005

Study information

• Verified date: June 2006
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of an experimental study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment of soft tissue sarcomas. Paclitaxel (Taxol®) has been approved and used in the United States since 1992.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be 18 years of age or older with histologic diagnosis of soft tissue sarcoma

• Must have disease not suitable for curative resection

• Must have failed >1 first line treatment with evidence of progression. Adjuvant therapy does not count as 1st line therapy unless recurrence occurs within 6 months of administration

• Must have ability to understand and the willingness to sign a written informed consent document

• Must have Eastern Cooperative Oncology Group (ECOG) performance status of < 2

• Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

• At least 4 weeks have passed since the last chemotherapy, immunotherapy, or radiation therapy

• There must be measurable disease outside the radiotherapy fields or progression of the indicator lesions within the field since the completion of the radiotherapy

• Must have a life expectancy of greater than 12 weeks

• Must have clinical laboratory values at screening as defined below:

• Hemoglobin >9 g/dL,

• Absolute neutrophil count >1500/mm3,

• Platelet count >100,000/mm3,

• Creatinine <1.5 X ULN,

• Bilirubin <1.5 X ULN,

• Asparate aminotransferase and alanine aminotransferase <2.5 X ULN (<5 X ULN in presence of liver metastases)

Exclusion Criteria:

• Female patients who are pregnant or breast feeding

• Patients of childbearing potential not using or not willing to use a barrier method of contraception

• Prior malignancy other than soft tissue sarcoma (STS) within the last 5 yrs with the exception of:

• Adequately treated in situ carcinoma of the cervix uteri;

• Basal or squamous cell carcinoma of the skin

• Presence of a clinically significant and uncontrolled infection

• Presence of >Grade 2 neuropathy

• Symptomatic central nervous system metastases within last 8 weeks or on corticosteroids for CNS symptom management

• Presence of clinically significant arrythmias

• Presence of a serious concurrent illness or other conditions (e.g., psychological, family, sociological, or geographical circumstances) that do not permit adequate follow-up and compliance with the protocol

• History of severe hypersensitivity reactions to taxanes or cremaphore in spite of premedication

• Use of any investigational agents within 4 weeks prior to the first dose of study drug(s)

• Major surgery within 2 weeks of screening

• Radiation treatment in past >25% of bone marrow

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• STA-4783

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	Winship Cancer Institute	Atlanta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Carolinas Medical Center/Blumenthal Cancer Center	Charlotte	North Carolina
United States	University of Chicago Department of Medicine	Chicago	Illinois
United States	Wayne State University	Detroit	Michigan
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	University of Florida	Gainesville	Florida
United States	MD Anderson Cancer Center	Houston	Texas
United States	UCLA	Los Angeles	California
United States	University of Louisville Hospital	Louisville	Kentucky
United States	The West Clinic	Memphis	Tennessee
United States	The Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Herbert Irving Cancer Center	New York	New York
United States	NYU Cancer Institute Clinical Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Hillman Cancer Center	Pittsburg	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Arizona Cancer Center	Scottsdale	Arizona
United States	Feist-Weiller Cancer Center	Shreveport	Louisiana
United States	Washington University School of Medicine	St. Louis	Missouri
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Arizona Cancer Center	Tucson	Arizona
United States	Palm Beach Cancer Institute	West Palm Beach	Florida
United States	Via Christi Regional Med. Center (Wichita CCOP)	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Countries where clinical trial is conducted

United States,  Canada,