Study Evaluating MST-997 in Advanced Malignant Solid Tumors
NCT00088647
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- Documented histological or cytological diagnosis confirming the presence of malignant solid tumor
- Tumor progression after conventional therapy for cancer or a malignant solid tumor for which no conventional therapy exists
- Subjects enrolled in the MTD confirmation cohort should have a documented histologic and/or cytologic diagnosis of metastatic breast cancer or non-small cell lung cancer (NSCLC) and should not have received more than 2 prior chemotherapy regimens for metastatic disease (adjuvant and neoadjuvant chemotherapy will not be included in the maximum of 2 prior regimens described above)
- Subjects with symptomatic or clinically active central nervous system (CNS)
metastases. Subjects who have had prior treatment with radiotherapy or surgical
resection for CNS metastases will be permitted if CNS metastases have remained stable
and have not required any treatment for at least 3 months prior to first dose of test
article
- History of any other primary malignancy with less than 5 years documentation of a
disease-free state (Subjects with a history of basal cell or squamous cell carcinomas
of the skin or cervical carcinoma in situ, which have been successfully treated, are
not excluded)
- Recent major surgery (within 14 days before the first dose) or chemotherapy within 28
days before the first dose of MST-997 (42 days if the previous chemotherapy included
nitrosoureas or mitomycin C)
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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 Intralipid 20% Administered Weekly in Subjects With Advanced Malignant Solid Tumors | |||
Brief Summary | The primary objective of this clinical research study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of intravenous (IV) MST-997 formulated in Intralipid 20% administered on a weekly schedule to subjects with advanced malignant solid tumors. | |||
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 | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
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 | NCT00088647 | |||
Other Study ID Numbers ICMJE | 3161K1-100 | |||
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 |