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A Study of NOV140201 (JPI-547) in Subject With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335604
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Collaborator:
Jeil Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
National OncoVenture

Tracking Information
First Submitted Date  ICMJE January 31, 2018
First Posted Date  ICMJE April 6, 2020
Last Update Posted Date April 6, 2020
Actual Study Start Date  ICMJE December 6, 2017
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
Dose-limiting toxicity (DLT) and Maximum tolerated dose (MTD) [ Time Frame: 21days ]
subjects will be treated and observed for DLT through the end of the first cycle
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
  • Area under the plasma concentration versus time curve (AUC) of JPI-547 [ Time Frame: 1 and 15 days ]
    to observe pharmacokinetic parameter
  • Peak Plasma Concentration (Cmax) of JPI-547 [ Time Frame: 1 and 15 days ]
    to observe pharmacokinetic parameter
  • Time at maximum concentration(Tmax) of JPI-547 [ Time Frame: 1 and 15 days ]
    to observe pharmacokinetic parameter
  • Half-life of JPI-547 [ Time Frame: 1 and 15 days ]
    to observe pharmacokinetic parameter
  • Accumulation ratio of JPI-547 [ Time Frame: 1 and 15 days ]
    to observe pharmacokinetic parameter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of NOV140201 (JPI-547) in Subject With Advanced Solid Tumors
Official Title  ICMJE An Open-label, Dose-finding, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetic-pharmacodynamic Profile of NOV140201 (JPI-547), a Dual Inhibitor of PARP/TNK in Patients With Advanced Solid Tumors
Brief Summary To assess the Safety, Tolerability, and Pharmacokinetic-pharmacodynamic Profile and efficacy of JPI-547 in patients with advanced solid tumor.
Detailed Description

This is an open-label, Phase 1 dose escalation and expansion study of NOV140201 (JPI-547) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of JPI-547 in patients with advanced solid tumors after failure of standard of care.

Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. DLTs will be assessed as the primary endpoint in this trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: JPI-547
The dose levels will be escalated following a 3+3 dose escalation scheme.
Study Arms  ICMJE Experimental: JPI-547
Intervention: Drug: JPI-547
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2020)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients aged 19 years old or above
  • Patients that are histologically or cytologically confirmed advanced solid tumors and are refractory to or are able to receive standard of care
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy ≥12 weeks
  • Individuals who volunteer to give to the written consent to the participation after listening to sufficient explanation for this clinical study

Exclusion Criteria:

  • History of severe drug hypersensitivity or hypersensitivity to IP or similar class
  • Patients who have the confirmed medical history or surgery/procedure history as the followings:

    1. History of major surgery requiring general anesthesia or assisted respiration within 4 weeks prior to baseline (within 2 weeks for video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery)
    2. Severe cardiovascular disease (eg. myocardial infarction or unstable angina pectoris) within 24 weeks prior to baseline
    3. New York Heart Association Class III or IV heart failure within 24 weeks prior to baseline
    4. Severe cerebrovascular disease within 24 weeks prior to baseline
    5. Pulmonary artery thrombosis, deep vein thrombosis, or clinically severe pulmonary disease within 24 weeks prior to baseline
    6. Infection requiring the administration of systemic antibiotics, antivirals or other uncontrolled Grade ≥3 Active infectious disease within 2 weeks prior to baseline
    7. Symptomatic interstitial lung disease
    8. Poor recovery from hematologic toxicities in previous anticancer treatment (eg. >4 weeks of Grade 3≥ toxicities)
    9. Individuals who receive bone marrow or stem cell transplant with a high dose of chemotherapy
  • Individuals as accompanied by the following diseases:

    1. Hematologic malignancy other than lymphoma
    2. History of myelodysplastic syndrome (MDS) or pre-treatment cytogenetic test results indicative of the risk of MDS/acute myelocytic leukemia (AML)
    3. Patients with symptomatic with clinically significant or uncontrolled central nervous system (CNS) or brain metastasis (other than patients who discontinued the administration of systematic corticosteroid at least 4 weeks prior to baseline and who are radiologically and neurologically stable for ≥4 weeks)
    4. Patients with clinically significant abnormalities in the judgment of the investigator according to electrocardiogram findings
    5. Uncontrolled hypertension (systolic blood pressure>140mmHg or diastolic blood pressure >90mmHg)
    6. Bleeding diatheses
    7. History of active hepatitis B or C virus (hepatitis patients acceptable if HBV DNA and HCV RNA are <institutional lower limits)
    8. positive known human immunodeficiency virus (HIV)infection
    9. Severe neurological disorder and mental illness that may affect the study results in the opinion of the investigator
  • Individuals who have the following medication history:

    1. Individuals with medication history of PARP inhibitors or TNK inhibitors (This applies only to Part 2.)
    2. Individuals receiving chemotherapy, biological therapy, retinoid therapy, immunotherapy, hormone therapy or therapeutic/palliative radiotherapy for the treatment of advanced solid tumors within 4 weeks prior to baseline (except for the individuals who received nitrosourea or mitomycin within 6 weeks prior to baseline and biological target antibody within 6 weeks prior to baseline)
    3. Patients requiring the continuous administration of non-steroidal anti-inflammatory drug (NSAID) with a high bleeding risk
    4. Patients requiring continuous administration of systemic corticosteroid equivalent to Prednisone >10 mg/day
    5. Individuals who received antithrombotics, including antiplatelets and anticoagulants within 2 weeks of baseline, or expecting to require the administration during the clinical study (the administration of low molecular weight heparin (LMWH) is allowed for the management and prevention of venous thrombosis during the clinical study.)
    6. Individuals who start the new administration or dose change of bisphosphonate within 30 days of baseline among patients with breast cancer and prostatic cancer in a dose expansion cohort within 30 days of baseline (bisphosphonate administered stably for 30 days before baseline is allowed.)
  • Pregnant women, breastfeeding women, or female of childbearing potential and male who are not willing to practice abstinence or use appropriate contraception* during the clinical study and for 3 months after the administration of the IP
  • Individuals who were administered other IPs or the investigational device within 4 weeks prior to baseline
  • Individual considered ineligible or unavailable for this study for other reasons, in the opinion of the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hoon-Kyo Kim, MD +82-31-920-2784 miongsok@ncc.re.kr
Contact: Nam-Seok Baek +82-31-920-2782 i20371@ncc.re.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04335604
Other Study ID Numbers  ICMJE NOV140201-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National OncoVenture
Study Sponsor  ICMJE National OncoVenture
Collaborators  ICMJE Jeil Pharmaceutical Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account National OncoVenture
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP