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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Information provided by (Responsible Party): | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00514306 |
Purpose
Multicenter, open-label, phase 1, cohort dose escalation study to determine the maximum tolerated dose (MTD) of 3 intermittent OSI-906 dosing 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 Intermittent Oral OSI-906 Dosing in Patients With Advanced Solid Tumors |
| Enrollment: | 79 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Schedule 1
OSI-906 days 1-3 every 14 days
|
Drug: OSI-906
Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
|
|
Experimental: Schedule 2
OSI-906 days 1-5 every 14 days
|
Drug: OSI-906
Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
|
|
Experimental: Schedule 3
OSI-906 days 1-7 every 14 days
|
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 Dosing Schedule 1 (S1) (OSI-906 Once Daily (QD) Days 1-3 every 14 days). Dosing Schedule 2 (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 pharmacokinetic 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. Dosing Schedule 3 (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.
A 3-patient bridging dose cohort will be opened in S1 to qualitatively compare the 25 mg capsule with 100 mg capsule dosage strengths in order to confirm that no gross differences in safety or exposure exist between the formulations. In order to characterize the tablet, a 6-patient dose cohort will be opened to qualitatively examine the pharmacokinetics of this dosage form.
Once the MTD has been determined for S1 and once the safety and pharmacokinetic data from the tablet cohort have been reviewed, a Fed-Fasted Expansion Cohort will be opened.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients may have had prior therapy, providing the following conditions are met:
Adequate hematopoietic, hepatic, and renal function defined as follows:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United Kingdom | |
| Drug Development Unit, Royal Marsden Hospital | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Study Director: | Medical Monitor | Astellas Pharma Global Development |
More Information
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00514306 History of Changes |
| Other Study ID Numbers: | OSI-906-102, 2006-005938-20 |
| Study First Received: | August 7, 2007 |
| Last Updated: | September 12, 2011 |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Advanced Cancer Breast cancer Renal cancer Ovarian Cancer |
Metastatic Cancer Non-small cell lung cancer Colorectal cancer |