Status:
RECRUITING
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
Lead Sponsor:
Onconic Therapeutics Inc.
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
19-79 years
Phase:
PHASE1
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 adv...
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 ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed inoperable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
- Those with at least one measurable lesion in accordance with RECIST 1.1
- Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Those with an expected survival period ≥12 weeks
- Patients with adequate hematologic function, renal and hepatic function confirmed by the following criteria (During the screening period, laboratory tests can be retested only once.)
- Those who voluntarily decide to participate in this clinical study after hearing sufficient explanations and who consent in writing
Exclusion
- Those with a history of severe hypersensitivity to the investigational product or combination anticancer drugs.
- Those with the following medical history or surgical history/procedural history confirmed
- Other primary malignant tumors other than pancreatic cancer
- Major surgery that requires general anesthesia or breathing aid
- Severe cardiovascular disease
- New York Heart Association Class 3 or 4 heart failure
- Severe cerebrovascular disease t
- Pulmonary thrombosis, deep vein thrombosis, or bronchial asthma, obstructive pulmonary disease, and other life-threatening severe lung diseases
- Infections requiring administration of systemic antibiotics or antivirals, etc.
- Hematologic malignancy
- Those with the following diseases
- Massive ascites, pleural effusions requiring therapeutic paracentesis
- Neuropathy ≥Grade 2
- Diarrhea, chronic inflammatory bowel disease
- Intestinal paralysis, intestinal obstruction
- Diseases that make oral administration difficult or affect absorption
- Interstitial lung disease, pulmonary fibrosis
- Dialysis patient
- Patients with clinically significant symptoms or uncontrolled central nervous system or brain metastases
- j. Uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \>90 mmHg) k. Bleeding diatheses l. Active hepatitis B or C virus. m. Known human immunodeficiency virus (HIV) positive
- Those with a medication history of the following drugs
- Anti-cancer drug therapy such as chemotherapy and biological therapy
- Radiation therapy within 2 weeks of baseline
- Those who are taking or expected to require administration of strong inhibitors or inducers of CYP3A4
- (For mFOLFIRINOX cohort) Those who are taking or expected to require administration of sorivudine
- Patients who require continuous administration of non-steroidal anti-inflammatory drugs (NSAIDs) with high bleeding risk
- Patients requiring continuous administration of systemic corticosteroid equivalent to prednisone \>10 mg/day
- Those who have received antithrombotic agents, including antiplatelet agents, anticoagulants, etc.
- Pregnant women, lactating women, or women of childbearing potential and men who do not intend to practice abstinence or use appropriate contraceptive methods for until 6 months for men and 9 months for women after administration of the investigational product and during the clinical study
- Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline
- Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05257993
Start Date
March 30 2022
End Date
June 1 2026
Last Update
February 19 2025
Active Locations (4)
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1
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
2
Samsung Medical Center
Seoul, South Korea
3
Seoul national university hospital
Seoul, South Korea
4
Severance Hospital
Seoul, South Korea