Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086528
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2004-07-02
Brief Title:
Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
Sponsor:
Kadmon Corporation LLC
Organization:
Kadmon Corporation LLC
Study Overview
Official Title:
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-05
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:
The primary objective of this study is as follows
To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors
The secondary objectives of this study are as follows
To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors
To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors
The exploratory objective of this study is as follows
To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral blood cells
In addition subjects may be eligible to enter a Treatment Extension Period The following information will be obtained from this part of the study
Long-term safety and tolerability of XL647 after repeat administration
Tumor response after repeat administration of XL647
To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors
The secondary objectives of this study are as follows
To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors
To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors
The exploratory objective of this study is as follows
To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral blood cells
In addition subjects may be eligible to enter a Treatment Extension Period The following information will be obtained from this part of the study
Long-term safety and tolerability of XL647 after repeat administration
Tumor response after repeat administration of XL647
Detailed Description:
None
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