Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04796454
Status:
WITHDRAWN
Last Update Posted:
2022-06-01
First Post:
2021-02-01
Brief Title:
Pamiparib and Low Dose Temozolomide In Patients With Platinum Sensitive Biliary Tract Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Pamiparib and Low Dose Temozolomide In Patients With Platinum Sensitive Biliary Tract Cancer
Status:
WITHDRAWN
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAMICC
Brief Summary:
The main objective of this trial is to evaluate the activity of pamiparib plus low dose TMZ as maintenance treatment in improving progression free survival PFS in patients with advanced BTC who have received first line platinum-based chemotherapy
The primary objective is to test with a one-sided type I error of 10 whether pamiparib plus low dose TMZ as maintenance treatment increases PFS according to RECIST version 11 in the entire study population as compared to standard treatment with Cisplatin-Gemcitabine chemotherapy regimen or Gemcitabine-Oxaliplatin if cisplatin is contra-indicated
This is an open label randomized controlled multi-center phase II trial
Patients must meet all the criteria to be eligible Eligible patients will be centrally randomized between the two arms in a 11 ratio Randomization will be stratified by the following factors
Tumour response CRPR vs SD vs non-measurablenon-PD after previous platinum-based chemotherapy as confirmed by central review
Tumour location intrahepatic bile ducts vs gallbladder vs perihilar bile ducts and distal bile duct and ampulla of Vater tumours
Patients will receive treatment until progression or for a maximum period of 2 years
The primary objective is to test with a one-sided type I error of 10 whether pamiparib plus low dose TMZ as maintenance treatment increases PFS according to RECIST version 11 in the entire study population as compared to standard treatment with Cisplatin-Gemcitabine chemotherapy regimen or Gemcitabine-Oxaliplatin if cisplatin is contra-indicated
This is an open label randomized controlled multi-center phase II trial
Patients must meet all the criteria to be eligible Eligible patients will be centrally randomized between the two arms in a 11 ratio Randomization will be stratified by the following factors
Tumour response CRPR vs SD vs non-measurablenon-PD after previous platinum-based chemotherapy as confirmed by central review
Tumour location intrahepatic bile ducts vs gallbladder vs perihilar bile ducts and distal bile duct and ampulla of Vater tumours
Patients will receive treatment until progression or for a maximum period of 2 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None