Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-29 @ 8:21 AM
Study NCT ID:
NCT02312804
Status:
WITHDRAWN
Last Update Posted:
2015-02-16
First Post:
2014-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ph Ib/BGJ398/Cervix and Other Solid Tumors
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
Study Overview
Official Title:
A Phase Ib Study Evaluating BGJ398 in Combination With Chemotherapeutic Regimen in Patients With Stage IV, Recurrent or Persistent Carcinoma of The Cervix and Other Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug not available.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be conducted using 3+3 design and includes, a dose escalation part to define the MTDfRP2D for the combination of BGJ398 and carboplatin/paclitaxel, and a dose expansion part to treat another 12 patients (only cervix cancer) to further evaluate safety of this combination. Safety, tolerability and MTD will be determined in the dose escalation part of the study. The dose expansion will additionally investigate preliminary anti-tumor efficacy in cervical cancer. The dosing cycle is 21 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: