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| Tracking Information | |||||
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| First Received Date ICMJE | August 7, 2007 | ||||
| Last Updated Date | August 3, 2009 | ||||
| Start Date ICMJE | December 2006 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of OSI-906 [ Time Frame: 2.5 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00514007 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety profile, Pharmacokinetic profile, Pharmacodynamic relationships, Preliminary antitumor activity [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Phase 1 Study of Continuous OSI-906 Dosing | ||||
| Official Title ICMJE | A Phase I Dose Escalation Study of Continuous Oral OSI-906 Dosing in Patients With Advanced Solid Tumors | ||||
| Brief Summary | Multicenter, open-label, phase 1, cohort dose escalation study to determine the MTD on both QD and BID schedules. |
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| Detailed Description | Multicenter, open-label, phase 1, cohort dose escalation. The study will open with the QD schedule, with initiation of the BID schedule occurring after observation of clinically significant related toxicity >/= grade 2 in the QD schedule. Dosing will be initiated on Day 1 with daily dosing (either QD or BID) continuing for 21 days. Patients may continue to receive OSI-906 until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study | ||||
| Condition ICMJE | Advanced Solid Tumors | ||||
| Intervention ICMJE | Drug: OSI-906 | ||||
| Study Arms / Comparison Groups |
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| 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 | 60 | ||||
| Estimated Completion Date | March 2010 | ||||
| Estimated Primary Completion Date | December 2009 (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, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00514007 | ||||
| Responsible Party | Karsten Witt, MD, VP Clinical Development, OSI Pharmaceuticals | ||||
| Study ID Numbers ICMJE | OSI-906-101 | ||||
| Study Sponsor ICMJE | OSI Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | OSI Pharmaceuticals | ||||
| Verification Date | July 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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