Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05412706
Status:
WITHDRAWN
Last Update Posted:
2023-09-08
First Post:
2022-05-25
Brief Title:
Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
Sponsor:
Ospedale Policlinico San Martino
Organization:
Ospedale Policlinico San Martino
Study Overview
Official Title:
Niraparib Maintenance Treatment in Metastatic Colorectal Cancer Patients With a Partial or Complete Response After Oxaliplatin-based Induction Therapy Bohème Trial
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Principal Investigator has retired and has not been replaced has retired and a new one has not been identified Principal Investigator
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bohème
Brief Summary:
Colorectal Cancer ranks third among the most frequent malignancies representing a leading cause of cancer-related death worldwide The constant improvement in the continuum of care of metastatic colorectal cancer mCRC patients led to a median overall survival of about 30-36 months
Due to the cumulative toxicities of first-line combinations of chemotherapy and biological agents discontinuation or intermittent chemotherapy or maintenance strategies have been investigated in clinical trials After a 4 to 6-month induction treatment with bevacizumab plus doublet or triplet regimens a fluoropyrimidine plus bevacizumab is regarded as the optimal maintenance regimen Little evidence is available on the role of maintenance with anti-EGFR agents
A recent systematic review and network meta-analysis of 12 relevant randomized clinical trials comprising 5540 patients with mCRC showed that a maintenance strategy with a fluoropyrimidine with or without the addition of bevacizumab is preferred However given the lack of a clear overall survival benefit shared decision-making should include observation as an acceptable alternative
PolyADP-ribose polymerase PARP inhibitors are now approved for breast ovarian and pancreatic cancers Evidence suggests that PARP inhibitors are more effective in tumors harboring homologous recombination DNA damage repair HRR deficiency and platinum sensitivity may be used a surrogate marker of HRD and therefore of PARP-inhibitors efficacy An extensive Next Generation Sequencing analysis revealed that 15 of mCRC samples harbors mutations in genes involved in the HRR pathway Several clinical trials are ongoing to test PARP inhibitors either alone or in combination in mCRC patients The originality of this trial is to investigate PARPi in the maintenance setting
Pre-clinical evidence showed that PARP blockade after initial oxaliplatin response delayed disease progression in mCRC carrying Kirsten Rat Sarcoma and BRAF mutations suggesting that maintenance treatment with PARP inhibitors warrants further clinical investigation in mCRC patients who respond to oxaliplatin-containing induction treatment
The main objective of this trial is to investigate the efficacy of anti-PARP inhibition as maintenance treatment in mCRC patients who obtained a complete or partial response after 4-month induction treatment with oxaliplatin-based double or triplet plus biologic agents
Due to the cumulative toxicities of first-line combinations of chemotherapy and biological agents discontinuation or intermittent chemotherapy or maintenance strategies have been investigated in clinical trials After a 4 to 6-month induction treatment with bevacizumab plus doublet or triplet regimens a fluoropyrimidine plus bevacizumab is regarded as the optimal maintenance regimen Little evidence is available on the role of maintenance with anti-EGFR agents
A recent systematic review and network meta-analysis of 12 relevant randomized clinical trials comprising 5540 patients with mCRC showed that a maintenance strategy with a fluoropyrimidine with or without the addition of bevacizumab is preferred However given the lack of a clear overall survival benefit shared decision-making should include observation as an acceptable alternative
PolyADP-ribose polymerase PARP inhibitors are now approved for breast ovarian and pancreatic cancers Evidence suggests that PARP inhibitors are more effective in tumors harboring homologous recombination DNA damage repair HRR deficiency and platinum sensitivity may be used a surrogate marker of HRD and therefore of PARP-inhibitors efficacy An extensive Next Generation Sequencing analysis revealed that 15 of mCRC samples harbors mutations in genes involved in the HRR pathway Several clinical trials are ongoing to test PARP inhibitors either alone or in combination in mCRC patients The originality of this trial is to investigate PARPi in the maintenance setting
Pre-clinical evidence showed that PARP blockade after initial oxaliplatin response delayed disease progression in mCRC carrying Kirsten Rat Sarcoma and BRAF mutations suggesting that maintenance treatment with PARP inhibitors warrants further clinical investigation in mCRC patients who respond to oxaliplatin-containing induction treatment
The main objective of this trial is to investigate the efficacy of anti-PARP inhibition as maintenance treatment in mCRC patients who obtained a complete or partial response after 4-month induction treatment with oxaliplatin-based double or triplet plus biologic agents
Detailed Description:
Multicenter phase II no profit study investigating the disease-free survival efficacy of niraparib as maintenance treatment in 46 patients with metastatic colorectal cancer with partial or complete response after oxaliplatin-based induction therapy
The study also includes translational research objectives
The study also includes translational research objectives
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