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Sponsored by: |
OSI Pharmaceuticals |
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Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00514306 |
Multicenter, open-label, phase 1, cohort dose escalation study to determine the MTD of 3 intermittent dosing 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 Intermittent Oral OSI-906 Dosing in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 75 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Schedule 1 (OSI-906 days 1-3 every 14 days)
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Drug: OSI-906
Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
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2: Experimental
Schedule 2 (OSI-906 days 1-5 every 14 days)
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Drug: OSI-906
Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
|
3: Experimental
Schedule 3 (OSI-906 days 1-7 every 14 days)
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Drug: OSI-906
Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
|
Multicenter, open-label, phase 1, cohort dose escalation. The study will open with S1 (OSI-906 QD Days 1-3 every 14 days). S2 (OSI-906 QD Days 1-5 every 14 days) will be initiated following observation of clinically significant related toxicity >/= grade 2 in S1 or after a review of preliminary safety and PK data from >/= 6 dose levels in S1 indicate that toxicity is acceptable and potential improvement in exposure may be achieved by an increased number of dosing days. S3 (OSI-906 QD Days 1-7 every 14 days) will occur upon observation of clinically significant related toxicity >/= grade 2 in S2 or after >/= 1 dose level in S2 has been examined. In each schedule, a single dose will be administered on each of the specified days followed by a drug-free period through to Day 14. A treatment period is defined as 14 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: OSIP Medical Informaiton | 800.572.1932 ext 7821 | medical-information@osip.com |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: OSIP Medical Informaiton 800-572-1932 ext 7821 medical-information@osip.com | |
United Kingdom, Surrey | |
Cancer Research UK Professor of Medical Oncology | Recruiting |
Sutton, Surrey, United Kingdom, SM2 5PT | |
Contact: OSIP Medical Informaiton 800.572.1932 ext 7821 medical-information@osip.com |
Study Director: | Andrew Stephens, M.D., PhD | OSI Pharmaceuticals |
Responsible Party: | OSI Pharmaceuticals ( Karsten Witt, MD, VIP Clinical Development ) |
Study ID Numbers: | OSI-906-102 |
Study First Received: | August 7, 2007 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00514306 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Advanced Cancer Breast cancer Renal cancer Ovarian Cancer |
Metastatic Cancer Non-small cell lung cancer Colorectal cancer |
Ovarian cancer Non-small cell lung cancer Ovarian Neoplasms Kidney Neoplasms Lung Neoplasms Carcinoma, Renal Cell |
Neoplasm Metastasis Breast Neoplasms Renal cancer Kidney cancer Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms |