Neoplasms
Conditions
Keywords
malignant tumor
Brief summary
MST-997 is a taxane analog with the potential to treat subjects with a variety of tumor types. Preclinical data demonstrated that MST-997 inhibited tumor growth when administered intravenously (IV). This phase 1 dose escalation study is designed to evaluate the safety and tolerability of if IV MST-997 formulated in Polysorbate 80 Diluent can be safely administered on a weekly basis.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Documented diagnosis of malignant solid tumor with measurable disease * Life expectancy of at least 12 weeks * ECOG (Eastern Cooperative Oncology Group) performance status of 0,1,or 2
Exclusion criteria
* Recent major surgery, radiation therapy or anti-cancer treatment * History of any other prior malignancy within last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety, tolerability and MTD (maximum tolerated dose) of MST-997. | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary pharmacokinetic information on the pharmacokinetics (during cycle 1) abd anti-tumor activity (assessed approximately every 8 weeks) of on MST-997 | — |
Countries
United States