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| Sponsored by: |
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
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: | May 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00514007 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Non-small cell lung cancer Ovarian cancer Renal cancer Advanced Cancer |
Metastatic cancer Breast cancer Colorectal cancer |
|
Kidney Cancer Renal Cancer Ovarian Neoplasms Kidney Neoplasms Lung Neoplasms Carcinoma, Renal Cell |
Neoplasm Metastasis Non-small Cell Lung Cancer Ovarian Cancer Breast Neoplasms Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms |