Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483555
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-24
Brief Title:
Basal-like PDAC Treated With Gemcitabine Erlotinib and Nab-paclitaxel
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Subjects With Advanced Basal-like Pancreatic Adenocarcinoma Treated With Gemcitabine Erlotinib and Nab-paclitaxel PANGEA Versus Subjects With Classical Pancreatic Adenocarcinoma Treated With Triplet Standard of Care Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
PANGEA
Brief Summary:
This study explores the best dose of the combination treatment for subjects with advanced unresectable or metastatic basal-like subtype pancreatic adenocarcinoma For that reason the safety efficacy and tolerability as well as preliminary estimates of anti-tumor effects of low-dose epidermal growth factor receptor EGFR inhibitors in combination with bi-weekly gemcitabinenab-paclitaxel GnP will be examined in subjects with advanced basal-like pancreatic adenocarcinoma
The Purity Independent Subtyping of Tumors PurIST will determine the type of cancer either basal type or classical If cancer subtype-based first-line chemotherapy in combination with erlotinib will be safe and tolerable in subjects with advanced unresectable or metastatic pancreatic adenocarcinoma of the basal-like subtype as defined by PurIST as well as provide a preliminary assessment of treatment response in basal-like subjects This study will also follow a subset of subjects with classical subtypes that are treated per standard of care on oxaliplatin-based triplet chemotherapy
The Purity Independent Subtyping of Tumors PurIST will determine the type of cancer either basal type or classical If cancer subtype-based first-line chemotherapy in combination with erlotinib will be safe and tolerable in subjects with advanced unresectable or metastatic pancreatic adenocarcinoma of the basal-like subtype as defined by PurIST as well as provide a preliminary assessment of treatment response in basal-like subjects This study will also follow a subset of subjects with classical subtypes that are treated per standard of care on oxaliplatin-based triplet chemotherapy
Detailed Description:
The standard of care chemotherapy for first-line advanced pancreatic adenocarcinoma is FOLFIRINOX NALIRIFOX or gemcitabinenab-paclitaxel However multiple studies suggest that basal-like subtypes of pancreatic adenocarcinoma do not respond to FOLFIRINOX Based upon existing retrospective analyses the addition of epidermal growth factor receptor EGFR inhibitors such as erlotinib to gemcitabine and nab-paclitaxel suggest improved rates of response in subjects with basal-like pancreatic adenocarcinoma compared to FOLFIRINOX
Subjects with a classical subtype will be treated on standard-of-care oxaliplatin-based triplet chemotherapy Subjects with basal type will receive the erlotinib combination treatment The purpose of this study is to find out the best dose of the erlotinib combination treatment The erlotinib combination treatment is not FDA-approved However the combinations of erlotinib gemcitabine and nab-paclitaxel are both approved by the FDA for the treatment of pancreatic cancer The standard of care treatments are both FDA-approved All three drugs have been used in combination before in other clinical trials and a certain amount of safety data exists
In the basal-like arm of this study a two-stage utility of bayesian optimal interval U-BOIN design will be used to evaluate the range of safe and admissible doses in Stage 1 and the optimal best dose OBD in Stage 2 basal subjects After the determination of the OBD an expansion cohort will be enrolled to obtain additional precision of the overall response rate ORR In total 52 patients will be enrolled in the basal-like arm Separately 52 patients with classical tumors will be enrolled in a parallel arm and given standard-of-care oxaliplatin-based triplet chemotherapy FOLFIRINOX or NALIRIFOX to determine long-term outcomes including overall survival objective response rate and progression-free survival This is to test the safety and effectiveness how well a treatment works of both treatments depending on the cancer type
Subjects with a classical subtype will be treated on standard-of-care oxaliplatin-based triplet chemotherapy Subjects with basal type will receive the erlotinib combination treatment The purpose of this study is to find out the best dose of the erlotinib combination treatment The erlotinib combination treatment is not FDA-approved However the combinations of erlotinib gemcitabine and nab-paclitaxel are both approved by the FDA for the treatment of pancreatic cancer The standard of care treatments are both FDA-approved All three drugs have been used in combination before in other clinical trials and a certain amount of safety data exists
In the basal-like arm of this study a two-stage utility of bayesian optimal interval U-BOIN design will be used to evaluate the range of safe and admissible doses in Stage 1 and the optimal best dose OBD in Stage 2 basal subjects After the determination of the OBD an expansion cohort will be enrolled to obtain additional precision of the overall response rate ORR In total 52 patients will be enrolled in the basal-like arm Separately 52 patients with classical tumors will be enrolled in a parallel arm and given standard-of-care oxaliplatin-based triplet chemotherapy FOLFIRINOX or NALIRIFOX to determine long-term outcomes including overall survival objective response rate and progression-free survival This is to test the safety and effectiveness how well a treatment works of both treatments depending on the cancer type
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None