NCT00277836

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
Last Updated

December 8, 2006

Status Verified

December 1, 2006

First QC Date

January 13, 2006

Last Update Submit

December 7, 2006

Conditions

Neoplasms

Keywords

malignant tumor

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

MST-997DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Recent major surgery, radiation therapy or anti-cancer treatment
  • History of any other prior malignancy within last 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

MST 997

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Poland, WPWZMED@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Netherlands, trials-NL@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 16, 2006

Last Updated

December 8, 2006

Record last verified: 2006-12

Locations

US(1)