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| Sponsor: | OSI Pharmaceuticals |
|---|---|
| Information provided by: | OSI Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00514007 |
Purpose
Multicenter, open-label, phase 1, cohort dose escalation study to determine the MTD on both QD and BID schedules.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: OSI-906 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase I Dose Escalation Study of Continuous Oral OSI-906 Dosing in Patients With Advanced Solid Tumors |
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Once per day
|
Drug: OSI-906
Oral OSI-906 administered once daily at increasing doses until disease progression or unacceptable toxicity
|
|
2: Experimental
Twice per day
|
Drug: OSI-906
Oral OSI-906 administered twice daily at increasing doses until disease progression or unacceptable toxicity
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: OSIP Medical Information | 800.572.1932, x7821 | medical-information@osip.com |
| United States, Tennessee | |
| Vanderbilt Universtiy Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6307 | |
| Contact: OSIP Medical Information 800-572-1932 ext 7821 medical-information@osip.com | |
| United Kingdom | |
| The Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Contact: OSIP Medical Information 800.572.1932 ext 7821 medical-information@osip.com | |
| Study Director: | Andrew Stephens, M.D., PhD | OSI Pharmaceuticals |
More Information
| Responsible Party: | OSI Pharmaceuticals ( Karsten Witt, MD, VP Clinical Development ) |
| Study ID Numbers: | OSI-906-101 |
| Study First Received: | August 7, 2007 |
| Last Updated: | August 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00514007 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Non-small cell lung cancer Ovarian cancer Renal cancer Advanced Cancer |
Metastatic cancer Breast cancer Colorectal cancer |