Study Evaluating MST-997 in Advanced Malignant Solid Tumors

Phase 1

Terminated

• Conditions: Neoplasms

• Registration Number: NCT00277836
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-13
• Study First Submitted QC: 2006-01-13
• Study First Posted: 2006-01-16
• Status Verified: 2006-12
• Last Update Submitted: 2006-12-07
• Last Update Posted: 2006-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
To evaluate the safety, tolerability and MTD (maximum tolerated dose) of MST-997.

Secondary Outcome Measures

Name	Time	Method
Preliminary pharmacokinetic information on the pharmacokinetics (during cycle 1) abd anti-tumor activity (assessed approximately every 8 weeks) of on MST-997