An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer
NCT06532344 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2024-11-14
Summary
To investigate the tolerability and safety of ONO-7913 and ONO-4538 used in combination with modified FOLFIRINOX (mFFX therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.
Conditions
Interventions
- DRUG
-
ONO-7913
Specified dose on specified days
- DRUG
-
ONO-4538
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Levofolinate
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
-
Ono Pharmaceutical Co. Ltd
lead INDUSTRY
Principal Investigators
-
Project Leader · Ono Pharmaceutical Co. Ltd
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-30
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Japan
Study Locations
More Related Trials
-
FOLFIRINOX + NIS793 in Pancreatic Cancer
NCT05417386 ·Status: TERMINATED ·Phase: PHASE1
-
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
NCT06547385 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
FOLFIRINOX + Elraglusib + Losartan In Pancreatic Cancer
NCT05077800 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
FOLFIRINOX Plus IPI-926 for Advanced Pancreatic Adenocarcinoma
NCT01383538 ·Status: COMPLETED ·Phase: PHASE1
-
Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer
NCT01121848 ·Status: COMPLETED ·Phase: PHASE3
-
Induction Chemotherapy, FOLFIRINOX Followed With Concurrent Capecitabine and Radiation Therapy in Inoperable Locally Advanced Cancer of the Pancreas
NCT02311439 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer
NCT03699319 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Neo-adjuvant FOLF(IRIN)OX for Resectable Pancreatic Adenocarcinoma
NCT02959879 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer
NCT01523457 ·Status: COMPLETED ·Phase: PHASE2
-
PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy
NCT00364013 ·Status: COMPLETED ·Phase: PHASE3
-
Redefining FOLFIORINOX in Older Pancreatic Cancer Patients
NCT05360732 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study
NCT02345460 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy Study of mFOLFOX6 + Panitumumab Combination Therapy and 5-FU/LV + Panitumumab Combination Therapy in Participants With Chemotherapy-naïve Unresectable Advanced Recurrent Colorectal Carcinoma
NCT02337946 ·Status: COMPLETED ·Phase: PHASE2
-
Study Assessing Potential Predictive Tumor Markers in Metastatic Colorectal Cancer
NCT01288339 ·Status: COMPLETED ·Phase: PHASE2
-
Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC
NCT02394795 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients
NCT02980510 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
NCT06948448 ·Status: RECRUITING ·Phase: PHASE2
-
Phase II Study of 5-FU, Oxaliplatin Plus Dasatinib in Metastatic Pancreatic Adenocarcinoma
NCT01652976 ·Status: COMPLETED ·Phase: PHASE2
-
First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
NCT01289821 ·Status: COMPLETED ·Phase: PHASE2
-
BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study
NCT01744353 ·Status: COMPLETED ·Phase: PHASE1
-
Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies
NCT01643499 ·Status: COMPLETED ·Phase: PHASE1
-
Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer
NCT01666730 ·Status: COMPLETED ·Phase: PHASE2
-
First Line mFOLFOXIRI + PANITUMUMAB vs mFOLFOX + PANITUMUMAB IN RAS AND BRAF WT METASTATIC COLORECTAL CANCER PATIENTS
NCT03231722 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer
NCT05546411 ·Status: TERMINATED ·Phase: PHASE2
-
Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer
NCT00689624 ·Status: COMPLETED ·Phase: PHASE2