Study Evaluating MST-997 in Advanced Malignant Solid Tumors
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neoplasms
Intervention: MST-997 (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com
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.
Clinical Details
Official title: A Phase 1 Dose-Escalation Study of Intravenous MST-997 Formulated in Polysorbate 80 Diluent Administered Weekly in Subjects With Advanced Malignant Solid Tumors
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety Study
Primary outcome: To evaluate the safety, tolerability and MTD (maximum tolerated dose) of MST-997.
Secondary outcome: Preliminary pharmacokinetic information on the pharmacokinetics (during cycle 1) abd anti-tumor activity (assessed approximately every 8 weeks) of on MST-997
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Houston, Texas 77030, United States
Additional Information
Last updated: December 7, 2006
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