Pancreatic Ductal Adenocarcinoma Clinical Trial
Official title:
A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer
The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.
OT-01-P201 is designed as a randomized, open-label, active controlled, multicenter Phase 2B/Phase 3 study designed to compare the efficacy and safety of OT-101 in combination with modified FOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to modified FOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer. The primary endpoint of the study is overall survival and key secondary endpoints are progression-free survival and objective response rate. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05209074 -
Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
|
Phase 1 | |
| Recruiting |
NCT04969731 -
Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
|
Phase 3 | |
| Recruiting |
NCT04927780 -
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
|
Phase 3 | |
| Recruiting |
NCT05048524 -
Peri-operative SLOG for Localized Pancreatic Cancer
|
Phase 2 | |
| Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03257150 -
A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer
|
N/A | |
| Terminated |
NCT04400903 -
Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer
|
||
| Active, not recruiting |
NCT05462717 -
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03267316 -
A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04970056 -
Pancreatic Cancer Early Detection Consortium
|
||
| Terminated |
NCT04046887 -
Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
|
Phase 1 | |
| Recruiting |
NCT05964621 -
Venous Thromboembolism in Primary Pancreatic Tumour Resection
|
||
| Active, not recruiting |
NCT04827953 -
Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04291651 -
UCSF PANC Cyst Registry
|
||
| Recruiting |
NCT05977322 -
A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Recruiting |
NCT05692596 -
The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
|
||
| Active, not recruiting |
NCT04853017 -
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT04862260 -
Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma
|
Early Phase 1 | |
| Completed |
NCT03770117 -
Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease
|
||
| Completed |
NCT02259114 -
A Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003)
|
Phase 1 |