Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-23 @ 4:29 PM
Study NCT ID:
NCT00982566
Status:
COMPLETED
Last Update Posted:
2017-11-21
First Post:
2009-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess the Oral Bioavailability of a New ABT-263 Formulation in Subjects With Cancer
Sponsor:
AbbVie
Organization:
Study Overview
Official Title:
A Phase 1 Study Evaluating the Relative Oral Bioavailability of New Formulations of ABT-263 in Subjects With Cancer
Status:
COMPLETED
Status Verified Date:
2011-01
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:
This is a randomized, single dose, open-label, multicenter crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 48 evaluable subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors will be enrolled in this study.
Detailed Description:
Subjects who complete Part 1 of the study will be provided an opportunity to receive Formulation A under a continuous once daily dosing schedule during Part 2 of the study. Subjects enrolled in the second part of the study may continue to receive Formulation A under the continuous once daily dosing schedule for up to one year following the date of the last subject enrolled on study provided they continue to tolerate the drug, have no evidence of disease progression, and do not meet any of the protocol specific criteria for subject discontinuation.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: