Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
Study NCT ID:
NCT05257993
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2022-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety, Tolerability of JPI-547 in Combination With Modified FOLFIRINOX or Gemcitabine-nab-paclitaxel in Patients With Locally Advanced and Metastatic Pancreatic Cancer
Sponsor:
Onconic Therapeutics Inc.
Organization:
Study Overview
Official Title:
An Open-label, Dose-finding, Phase Ib Study to Assess the Safety, Tolerability of JPI-547, a Dual Inhibitor of PARP/Tankyrase, in Combination With Modified FOLFIRINOX (mFOLFIRINOX) or Gemcitabine-nab-paclitaxel (GemAbraxne) in Patients With Locally Advanced and Metastatic Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2025-02
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:
None
Brief Summary:
The purpose of this study is to assess the safety, tolerability of JPI-547 in combination with modified FOLFIRINOX (mFOLFIRINOX) or Gemcitabine-nab-paclitaxel (GemAbraxne) in patients with locally advanced and metastatic pancreatic cancer
Detailed Description:
In combination with JPI-547 and chemotherapy in patients with locally advanced/metastatic pancreatic cancer,
Primary Objectives
* To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
* To select the optimal combination chemotherapy based on the safety profile.
Secondary Objectives
* To assess the safety and toxicity.
* To evaluate anti-tumor activity.
Primary Objectives
* To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
* To select the optimal combination chemotherapy based on the safety profile.
Secondary Objectives
* To assess the safety and toxicity.
* To evaluate anti-tumor activity.
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?: