Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421889
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2007-01-12
Brief Title:
A Study of Belinostat Carboplatin or Paclitaxel or Both in Patients With Ovarian Cancer in Need of Relapse Treatment
Sponsor:
Valerio Therapeutics
Organization:
Valerio Therapeutics
Study Overview
Official Title:
A Phase III Safety Pharmacodynamic and Pharmacokinetic Study of Intravenously Administered PXD101 Plus Carboplatin or Paclitaxel or Both in Patients With Advanced Solid Tumours
Status:
COMPLETED
Status Verified Date:
2015-07
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 study seeks to assess the safety pharmacodynamics pharmacokinetics and efficacy of belinostat PXD101 administered in combination with carboplatin or paclitaxel or both in patients with solid tumours followed by maximum tolerated dose MTD expansion phase II in ovarian and bladder cancer patients
The clinical trial is now in the MTD phase II portion of the study enrolling bladder cancer patients Enrollment of ovarian patients is complete
The clinical trial is now in the MTD phase II portion of the study enrolling bladder cancer patients Enrollment of ovarian patients is complete
Detailed Description:
MTD Expansion IPhase II A total of 18-32 patients with epithelial ovarian primary peritoneal fallopian tube or mixed mullerian tumours of ovarian origin in need of relapse treatment will be enrolled
MTD Expansion II phase II A total of 15 patients with urothelial transitional cell carcinoma of the bladder will be enrolled
MTD Expansion II phase II A total of 15 patients with urothelial transitional cell carcinoma of the bladder will be enrolled
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 |
|---|---|---|---|
| PXD101-040-EU | None | None | None |