- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05257993
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
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Subin Lee
- Phone Number: 01066862968
- Email: sblee@onconic.co.kr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (mFOLFIRINOX)
JPI-547 and Combination Chemotherapy(mFOLFIRINOX) The study is conducted in a 3+3 dose escalation method.
|
|
Experimental: Arm B (GemAbraxane)
JPI-547 and Combination Chemotherapy (Gemcitabine-nab-paclitaxel) The study is conducted in a 3+3 dose escalation method.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
Time Frame: From the date of administration to 4 weeks (DLT period)
|
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.
|
From the date of administration to 4 weeks (DLT period)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Until 4 weeks after the last dose administration
|
|
To evaluate anti-tumor activity.
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
|
Anti-tumor activity is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
|
Evaluation at 8 weeks intervals through study completion from the date of study entry until the date of progression, up to 18 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
- Folfirinox
Other Study ID Numbers
- JPI-547-102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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