Clinical trial · Interventional
A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas
NCT00087997CI-TRIAL-00000355completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STA-4783 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.