Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514306
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2007-08-07
Brief Title:
Study of Intermittent OSI-906 Dosing
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase I Dose Escalation Study of Intermittent Oral OSI-906 Dosing in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multicenter open-label phase 1 cohort dose escalation study to determine the maximum tolerated dose MTD of 3 intermittent OSI-906 dosing schedules
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-005938-20 | EUDRACT_NUMBER | None | None |