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| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 9, 2002 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | November 2001 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00033215 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Phase 1 Study of S-3304 in Patients With Solid Tumors |
| Official Title ICMJE | A Phase 1 Study of S-3304 in Patients With Solid Tumors |
| Brief Summary | To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. To determine the pharmacokinetic profile of S-3304 in this patient population |
| Detailed Description | |
| Study Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Condition ICMJE | Solid Tumors |
| Intervention ICMJE | Drug: S-3304 |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Enrollment ICMJE | 28 |
| Completion Date | October 2003 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion criteria:
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| Gender | Both |
| Ages | 18 Years to 85 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00033215 |
| Responsible Party | |
| Study ID Numbers ICMJE | 0110P1416 |
| Study Sponsor ICMJE | Shionogi |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Shionogi |
| Verification Date | November 2003 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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