The purpose of this study is to assess the safety, tolerability and efficacy of JPI-547 in combination with modified FOLFIRINOX (mFOLFIRINOX) or Gemcitabine-nab-paclitaxel (GemAbraxne) in patients with locally advanced and metastatic pancreatic cancer
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
* Subjects are administered this investigational product once a week for 5 days, and have wash-out period for 2 days (5 Days on-2 Days off). * The investigational product is administered orally in a fasting state for 2 hours before and after meals at the same time (e.g., a certain time in the morning). * Capsules should be swallowed whole and should not be chewed, crushed or split.
* After IV administration of Oxaliplatin 65 mg/m2 for 2 hours * After IV administration of Leucovorin 400 mg/m2 for 2 hours + IV administration of Irinotecan 135 mg/m2 for 90 minutes (Irinotecan is started 30 minutes after the start of Leucovorin administration and administered simultaneously during the last 90 minutes of Leucovorin administration, but administered separately using a Y-connector without mixing) * Continuous IV infusion of 5-FU 2400 mg/m2 for 46 hours * Repeated administration every 2 weeks on a 14-day cycle
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGSeoul national university hospital
Seoul, South Korea
RECRUITINGPhase 1b: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
The MTD is determined according to the traditional 3+3 rule-based method for each combination therapy, and it is defined as the highest dose with a DLT incidence of less than 1/3 or 2/6 subjects.
Time frame: From the date of administration to 4 weeks (DLT period)
Phase 2: To determine the regimen of JPI-547 in combination with Chemotherapy GemAbraxane and to evaluate the potential antitumor activity and safety of the combination therapy.
Time frame: From first dose until disease progression, assessed up to end of study
To assess the adverse events, drug adverse events, and serious adverse events evaluated by NCI-CTCAE v5.0
Time frame: Until 4 weeks after the last dose administration
To evaluate anti-tumor activity.
Anti-tumor activity is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Evaluation at 8 weeks intervals through study completion from the date of study entry until the date of progression, up to 18 months
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* After IV administration of nab-paclitaxel 125 mg/m2 for 30 minutes * IV administration of Gemcitabine 1000 mg/m2 for 30 minutes * Administration on Days 1, 8, and 15 on a 28-day cycle
Severance Hospital
Seoul, South Korea
RECRUITING