Study Evaluating MST-997 in Advanced Malignant Solid Tumors

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00277836
• Other study ID #: 3161K1-101
• Status: Terminated
• Phase: Phase 1
• First received: January 13, 2006
• Last updated: December 7, 2006

Study information

• Verified date: December 2006
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• MST-997

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety, tolerability and MTD (maximum tolerated dose) of MST-997.
Secondary	Preliminary pharmacokinetic information on the pharmacokinetics (during cycle 1) abd anti-tumor activity (assessed approximately every 8 weeks) of on MST-997