Study Evaluating MST-997 in Advanced Malignant Solid Tumors

This study has been terminated.

First Received on January 13, 2006. Last Updated on December 7, 2006 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00277836

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: MST-997	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277836

Locations

United States, Texas

Houston, Texas, United States, 77030

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For Poland, WPWZMED@wyeth.com
Principal Investigator:	Trial Manager	For Netherlands, trials-NL@wyeth.com

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00277836 History of Changes
Other Study ID Numbers:	3161K1-101
Study First Received:	January 13, 2006
Last Updated:	December 7, 2006
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

malignant tumor

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012