Study Evaluating TTI-237 in Advanced Malignant Solid Tumors.
NCT00195325
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Adult Trials: 18+ Years
- Documented diagnosis of malignant solid tumor with measurable disease
- Life expectancy of at least 12 weeks
- ECOG (The Eastern Cooperative Oncology Group scale) performance status of 0, 1, or 2
- Recent major surgery, radiation therapy or anti-cancer treatment
- History of any other prior malignancy within the last 5 years
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating TTI-237 in Advanced Malignant Solid Tumors. | |||
| Official Title ICMJE | A Phase 1 Dose Escalation Study of TTI-237 Administered Intravenously (IV) Once Weekly in Subjects With Advanced Malignant Solid Tumors. | |||
| Brief Summary | The purpose of this study is to evaluate the safety, tolerability, and MTD (maximum tolerated dose) of TTI-237 for the treatment of 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: Educational/Counseling/Training | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: TTI-237 | |||
| 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 | 45 | |||
| 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 | NCT00195325 | |||
| Other Study ID Numbers ICMJE | 3162K1-100 | |||
| 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 | March 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||