Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01911273
Status:
TERMINATED
Last Update Posted:
2015-10-28
First Post:
2013-07-26
Brief Title:
A Study To Evaluate The Efficacy And Safety of The Investigational Drug PF-03446962 A Monoclonal Antibody With Antiangiogenic Features In Combination With Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients Affected By Recurrent Liver Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 2 Randomized Double Blind Study To Evaluate The Efficacy Safety Pharmacodynamics And Pharmacokinetics Of The Anti-alk-1 Monoclonal Antibody Pf-03446962 In Combination With Best Supportive Care Vs Placebo Plus Best Supportive Care In Adult Patients With Advanced Hepatocellular Carcinoma Following Failure Of Sorafenib
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of the study is to explore whether treatment with PF-03446962 and best supportive care is better than placebo plus best supportive care in prolonging survival of patients affected by recurrent liver cancer In addition the study will explore if adding PF-03446962 to best supportive care is safe how PF-03446962 is metabolized if there are patients characteristics biomarkers that may predict response to PF-03446962 and if PF-03446962 has any effect on the patients quality of life
Detailed Description:
This study was terminated on June 24th 2014 due to change in strategy of PF-03446962 clinical development There were no safety or efficacy concerns regarding the study behind the decision to terminate the trial The study was on temporary halt since March 10th and there are currently no patients on treatment or in the process of being randomized
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 |
|---|---|---|---|
| 2013-001426-26 | EUDRACT_NUMBER | None | None |