Study Evaluating MST-997 in Advanced Malignant Solid Tumors
NCT00277836
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Recent major surgery, radiation therapy or anti-cancer treatment
- History of any other prior malignancy within last 5 years
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Advanced Information
| Descriptive Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating MST-997 in Advanced Malignant Solid Tumors | |||||||||
| Official Title ICMJE | A Phase 1 Dose-Escalation Study of Intravenous MST-997 Formulated in Polysorbate 80 Diluent Administered Weekly in Subjects With Advanced Malignant Solid Tumors | |||||||||
| 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 Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 1 | |||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||
| Condition ICMJE | Neoplasms | |||||||||
| Intervention ICMJE | Drug: MST-997 | |||||||||
| Study Arms ICMJE | Not Provided | |||||||||
| Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Terminated | |||||||||
| Enrollment ICMJE | 60 | |||||||||
| Original Enrollment ICMJE | Same as current | |||||||||
| Study Completion Date ICMJE | Not Provided | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||||||||
| Sex/Gender ICMJE |
| |||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00277836 | |||||||||
| Other Study ID Numbers ICMJE | 3161K1-101 | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Not Provided | |||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
| |||||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Verification Date | December 2006 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||