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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 24, 2007 | ||||||||
| Last Updated Date | October 2, 2009 | ||||||||
| Start Date ICMJE | June 2007 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
adverse events and other safety assessments [ Time Frame: continuous ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
adverse events and other safety assessments [ Time Frame: continuous ] | ||||||||
| Change History | Complete list of historical versions of study NCT00506805 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
tumor response measured by X-rays or scans [ Time Frame: after every 2 cycles ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
tumor response measured by X-rays or scans [ Time Frame: after every 2 cycles ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety And Pharmacology Study Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies | ||||||||
| Official Title ICMJE | A Phase 1, Open-label, Dose-escalation Study Of The Safety And Pharmacokinetics Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies Or Non-Hodgkin's Lymphoma | ||||||||
| Brief Summary | Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in patients with cancer. |
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| Detailed Description | |||||||||
| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study | ||||||||
| Condition ICMJE | Cancer | ||||||||
| Intervention ICMJE | Drug: SNX-5422 | ||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 69 | ||||||||
| Estimated Completion Date | January 2011 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00506805 | ||||||||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||||||
| Study ID Numbers ICMJE | B1311001, SNX-5422-CLN1-001 | ||||||||
| Study Sponsor ICMJE | Pfizer | ||||||||
| Collaborators ICMJE | Serenex, Inc. | ||||||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||||||
| Verification Date | October 2009 | ||||||||
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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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