Ignite Creation Date:
2024-05-05 @ 10:44 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01177397
Status:
COMPLETED
Last Update Posted:
2022-12-13
First Post:
2010-08-05
Brief Title:
Study to Assess Safety Pharmacokinetics and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors Non-Hodgkin Lymphoma or Multiple Myeloma
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 12 Multi-Center Open-Label Dose Finding Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors Non-Hodgkin Lymphoma or Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2022-12
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 main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug dual mTOR inhibitors in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials
Detailed Description:
Initially patients will be treated with oral CC-223 for one month During this time various tests involving blood and urine collections ECGs etc will be performed Those whose tumors stabilize or regress may continue receiving treatment for as long as they benefit from CC-223 Different dose levels of CC-223 will be tested in a dose-rising study design
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