- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00277836
Study Evaluating MST-997 in Advanced Malignant Solid Tumors
December 7, 2006 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Phase 1 Dose-Escalation Study of Intravenous MST-997 Formulated in Polysorbate 80 Diluent Administered Weekly in Subjects With Advanced Malignant Solid Tumors
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.
Study Overview
Study Type
Interventional
Enrollment
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To evaluate the safety, tolerability and MTD (maximum tolerated dose) of MST-997.
|
Secondary Outcome Measures
Outcome Measure |
---|
Preliminary pharmacokinetic information on the pharmacokinetics (during cycle 1) abd anti-tumor activity (assessed approximately every 8 weeks) of on MST-997
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 13, 2006
First Submitted That Met QC Criteria
January 13, 2006
First Posted (Estimate)
January 16, 2006
Study Record Updates
Last Update Posted (Estimate)
December 8, 2006
Last Update Submitted That Met QC Criteria
December 7, 2006
Last Verified
December 1, 2006
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3161K1-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasms
-
GlaxoSmithKlineCompleted
-
Amphia HospitalRecruitingColonic Neoplasms MalignantNetherlands
-
Marquette General Health SystemUpper Michigan Brain Tumor CenterWithdrawnGlioma | MeningiomaUnited States
-
European Association for Endoscopic SurgeryWithdrawn
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedBrain Stem Neoplasms, Primary | Neoplasms, Brain StemUnited States
-
Moscow Clinical Scientific CenterRecruitingCecal Neoplasms | Colonic Neoplasms MalignantRussian Federation
-
GlaxoSmithKlineRecruitingNeoplasms, RectalUnited States, France, Italy, Japan, Spain, United Kingdom, Germany, Korea, Republic of, Canada, Netherlands
-
Russian Society of Colorectal SurgeonsRecruitingNeoplasms,ColorectalRussian Federation
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
Novartis PharmaceuticalsBayerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic NeoplasmsUnited States, Germany, Belgium, Canada, Spain, United Kingdom, Taiwan, France, Switzerland, Sweden, Portugal, New Zealand, Italy, Slovakia, Australia, Austria, Brazil, Hong Kong
Clinical Trials on MST-997
-
Wyeth is now a wholly owned subsidiary of PfizerTerminated
-
Centre for Addiction and Mental HealthUniversity of British Columbia; Brain Canada; Ontario Shores Centre for Mental...Active, not recruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
-
Centre for Addiction and Mental HealthUniversity of British Columbia; Brain Canada; Ontario Shores Centre for Mental...RecruitingDepression | Bipolar Depression | Treatment Resistant Depression | Unipolar DepressionCanada
-
De ViersprongRadboud University Medical Center; Koraal; Stichting tot Steun; Prisma; MST-Nethe...RecruitingBehavioural ProblemsNetherlands
-
Centre for Addiction and Mental HealthUniversity Health Network, TorontoCompletedDepressive Disorder | Schizophrenia | Schizoaffective Disorder | Obsessive-Compulsive DisorderCanada
-
University of British ColumbiaRecruitingDepression | Parkinson Disease | Movement Disorders | Major Depressive DisorderCanada
-
Centre for Addiction and Mental HealthCompletedBorderline Personality DisorderCanada
-
Bayside HealthCompletedTreatment Resistant DepressionAustralia
-
Mast Therapeutics, Inc.CompletedSickle Cell DiseaseUnited States
-
Wayne State UniversityMedical University of South Carolina; National Institute of Diabetes and Digestive...CompletedType 1 DiabetesUnited States