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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Information provided by (Responsible Party): | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00514007 |
Purpose
Multicenter, open-label, phase 1, cohort dose escalation study to determine the Maximum Tolerated Dose (MTD) on both Once Daily (QD) and Twice Daily (BID) schedules.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: OSI-906 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose Escalation Study of Continuous Oral OSI-906 Dosing in Patients With Advanced Solid Tumors |
| Enrollment: | 95 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: OSI-906 QD
Once per day
|
Drug: OSI-906
OSI-906 administered orally
|
|
Experimental: OSI-906 BID
Twice per day
|
Drug: OSI-906
OSI-906 administered orally
|
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.
Once the recommended phase 2 dose has been determined for the BID schedule, 2 expansion cohorts will be opened: 1) Biomarker Expansion Cohort in patients with locally advanced or metastatic colorectal cancer and 2) Diabetic Expansion Cohort in patients with advanced solid tumors who have active Type 2 diabetes mellitus not requiring insulin or insulinotropic therapy.
This study is currently only recruiting to the Biomarker and Diabetic Expansion Cohorts.
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| United States, Tennessee | |
| Vanderbilt Universtiy Medical Center | |
| Nashville, Tennessee, United States, 37232-6307 | |
| United Kingdom | |
| The Beatson West of Scotland Cancer Centre | |
| Glasgow, United Kingdom, G12 0YN | |
| Study Director: | Medical Director | Astellas Pharma Global Development |
More Information
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00514007 History of Changes |
| Other Study ID Numbers: | OSI-906-101, 2006-005937-39 |
| Study First Received: | August 7, 2007 |
| Last Updated: | January 5, 2012 |
| 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 |