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
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Registration Number
- NCT05257993
- Lead Sponsor
- Onconic Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria:<br><br> 1. Histologically or cytologically confirmed inoperable locally advanced or metastatic<br> pancreatic ductal adenocarcinoma (PDAC)<br><br> 2. Those with at least one measurable lesion in accordance with RECIST 1.1<br><br> 3. Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1<br><br> 4. Those with an expected survival period =12 weeks<br><br> 5. Patients with adequate hematologic function, renal and hepatic function confirmed by<br> the following criteria (During the screening period, laboratory tests can be<br> retested only once.)<br><br> 6. Those who voluntarily decide to participate in this clinical study after hearing<br> sufficient explanations and who consent in writing<br><br>Exclusion Criteria:<br><br> 1. Those with a history of severe hypersensitivity to the investigational product or<br> combination anticancer drugs.<br><br> 2. Those with the following medical history or surgical history/procedural history<br> confirmed<br><br> 1. Other primary malignant tumors other than pancreatic cancer<br><br> 2. Major surgery that requires general anesthesia or breathing aid<br><br> 3. Severe cardiovascular disease<br><br> 4. New York Heart Association Class 3 or 4 heart failure<br><br> 5. Severe cerebrovascular disease t<br><br> 6. Pulmonary thrombosis, deep vein thrombosis, or bronchial asthma, obstructive<br> pulmonary disease, and other life-threatening severe lung diseases<br><br> 7. Infections requiring administration of systemic antibiotics or antivirals, etc.<br><br> 8. Hematologic malignancy<br><br> 3. Those with the following diseases<br><br> 1. Massive ascites, pleural effusions requiring therapeutic paracentesis<br><br> 2. Neuropathy =Grade 2<br><br> 3. Diarrhea, chronic inflammatory bowel disease<br><br> 4. Intestinal paralysis, intestinal obstruction<br><br> 5. Diseases that make oral administration difficult or affect absorption<br><br> 6. Interstitial lung disease, pulmonary fibrosis<br><br> 7. Dialysis patient<br><br> 8. Patients with clinically significant symptoms or uncontrolled central nervous<br> system or brain metastases<br><br> j. Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood<br> pressure >90 mmHg) k. Bleeding diatheses l. Active hepatitis B or C virus. m. Known<br> human immunodeficiency virus (HIV) positive<br><br> 4. Those with a medication history of the following drugs<br><br> 1. Anti-cancer drug therapy such as chemotherapy and biological therapy<br><br> 2. Radiation therapy within 2 weeks of baseline<br><br> 3. Those who are taking or expected to require administration of strong inhibitors<br> or inducers of CYP3A4<br><br> 4. (For mFOLFIRINOX cohort) Those who are taking or expected to require<br> administration of sorivudine<br><br> 5. Patients who require continuous administration of non-steroidal<br> anti-inflammatory drugs (NSAIDs) with high bleeding risk<br><br> 6. Patients requiring continuous administration of systemic corticosteroid<br> equivalent to prednisone >10 mg/day<br><br> 7. Those who have received antithrombotic agents, including antiplatelet agents,<br> anticoagulants, etc.<br><br> 5. Pregnant women, lactating women, or women of childbearing potential and men who do<br> not intend to practice abstinence or use appropriate contraceptive methods for until<br> 6 months for men and 9 months for women after administration of the investigational<br> product and during the clinical study<br><br> 6. Those who have administered other investigational products or have received<br> investigational medical device procedures within 4 weeks of the baseline<br><br> 7. Other patients who are inappropriate or unable to participate in this clinical study<br> at the discretion of the investigator
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
- Secondary Outcome Measures
Name Time Method To assess the adverse events, drug adverse events, and serious adverse events evaluated by NCI-CTCAE v5.0;To evaluate anti-tumor activity.