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

Synta Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Soft Tissue Sarcoma

Treatments

Drug: STA-4783

Study type

Interventional

Funder types

Industry

Identifiers

NCT00087997

4783-04

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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