Ignite Creation Date:
2024-05-06 @ 2:50 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02139904
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2014-05-09
Brief Title:
Vinorelbine in Mesothelioma
Sponsor:
Wales Cancer Trials Unit
Organization:
Wales Cancer Trials Unit
Study Overview
Official Title:
A Randomised Phase II Trial of Oral Vinorelbine as Second Line Therapy for Patients With Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2021-10
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:
VIM
Brief Summary:
This study is for patients with malignant mesothelioma of the lung lining called pleura who have had previous chemotherapy with a platinum-based regimen whose disease has progressed Malignant pleural mesothelioma MPM is an aggressive frequently drug resistant and incurable disease that is increasing in incidence in the UK and worldwide All patients with MPM will relapse following first line chemotherapy and at present there is no standard treatment available for patients in the second line setting The vinca alkaloid chemotherapy drug vinorelbine has shown promising activity in a single arm UK trial However to date there has been no randomised evaluation of vinorelbine in mesothelioma in the second line setting In addition there have been no trials which have looked at underlying molecular changes in mesothelioma which may predict vinorelbine efficacy This might allow vinorelbine to be used in patients only where there is a chance of benefit Studies suggest that vinorelbine requires a gene called BRCA1 shown to be absent in 38 of mesothelioma cases in order to induce cell death in mesothelioma The VIM trial aims to establish whether vinorelbine in patients with MPM helps them live longer and whether the BRCA1 gene is helpful in selecting patients most likely to benefit from treatment
Patients will be randomised 12 to receive either active symptom control ASC which is all supportive care deemed necessary for pain management excluding disease modifying treatment or ASC with vinorelbine Patients will continue vinorelbine treatment until evidence of disease progression or unacceptable toxicity to the drug or patient withdrawal If vinorelbine activity is demonstrated we will use the results from this trial to inform the design of a future phase III trial
Patients will be randomised 12 to receive either active symptom control ASC which is all supportive care deemed necessary for pain management excluding disease modifying treatment or ASC with vinorelbine Patients will continue vinorelbine treatment until evidence of disease progression or unacceptable toxicity to the drug or patient withdrawal If vinorelbine activity is demonstrated we will use the results from this trial to inform the design of a future phase III trial
Detailed Description:
None
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