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Trial record 2 of 3 for:    IDX-1197

Study to Assess the Safety & Tolerability of NOV140101(IDX-1197) in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03317743
Recruitment Status : Active, not recruiting
First Posted : October 23, 2017
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
IlDong Pharmaceutical Co Ltd
National OncoVenture
Information provided by (Responsible Party):
Idience Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 18, 2017
First Posted Date  ICMJE October 23, 2017
Last Update Posted Date January 15, 2021
Actual Study Start Date  ICMJE August 29, 2017
Actual Primary Completion Date December 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
Dose Limiting Toxicities (DLTs) [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Safety & Tolerability of NOV140101(IDX-1197) in Patients With Advanced Solid Tumors
Official Title  ICMJE Open-label, Phase I Clinical Trial to Identify Optimal Dose and Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Anti-cancer Efficacy of NOV140101(IDX-1197HCl) in Patients With Advanced Solid Tumors
Brief Summary the purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV140101 (IDX-1197).
Detailed Description This is an open-label, Phase 1 dose escalation study of NOV140101 (IDX-1197) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of IDX-1197 in patients with advanced solid tumors after failure of standard of care. 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: NOV140101 (IDX-1197)
The dose levels will be escalated following a 3+3 dose escalation scheme.
Other Name: IDX-1197
Study Arms  ICMJE Experimental: NOV140101 (IDX-1197)
Intervention: Drug: NOV140101 (IDX-1197)
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 13, 2021)
32
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2017)
50
Estimated Study Completion Date  ICMJE June 2021
Actual Primary Completion Date December 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥19 year old patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors
  • Life expectancy ≥12 weeks
  • Women of childbearing potential must have a negative pregnancy test outcome
  • ECOG performance status ≤2
  • Lesions measured by tumor markers or CT/MRI and evaluable according to RECIST v1.1
  • Patient must have adequate organ function as indicated by the following laboratory values independent of transfusion within 2 weeks:

    1. ANC ≥ 1,500/mm³
    2. Platelet count ≥ 100,000/mm³
    3. Hemoglobin ≥ 9.0g/dL
    4. Serum creatinine ≤ 1.5×ULN
    5. Total bilirubin ≤ 1.5×ULN
    6. AST, ALT ≤ 3×ULN (≤ 5×ULN for patients with liver metastasis or liver cell cancer)
    7. PT and aPTT ≤ 1.5×ULN
    8. UPC < 1.0 g/g (one re-test is allowed if positive (≥ 1))
  • Patients must provide written informed consent to voluntary participation in this study.

Exclusion Criteria:

  • History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class
  • New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled hypertension (systolic/diastolic blood pressure >140/90mmHg), or other clinically significant cardiovascular abnormalities in the opinion of the investigator
  • Uncontrolled cardiac arrhythmia
  • Acute coronary syndrome (unstable angina pectoris or myocardial infarction) within the past 6 months
  • Major electrocardiogram (ECG) abnormalities in the opinion of the investigator
  • Severe infection or severe traumatism
  • Pneumonia or respiratory symptoms, such as dyspnea, cough, and fever, requiring treatment and other conditions likely to be accompanied by hypoxemia
  • History of drug or alcohol abuse within the past 3 months
  • Symptomatic or uncontrolled central nervous system (CNS) metastasis
  • Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a minor surgery
  • Radiotherapy, hormone therapy, or chemotherapy within 2 weeks prior to baseline from which toxicities not recovered to ≤grade 1
  • >4 weeks of persistent Grade 3 (NCI-CTCAE v4.03) hematologic toxicities from prior anticancer treatment
  • History of myelodysplastic syndrome (MDS) or pre-treatment cytogenetic test results indicative of the risk of MDS or acute myelocytic leukemia
  • Ongoing or anticipated treatment with antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, etc.) during the study
  • Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
  • Ongoing or past treatment with immunosuppressants within 14 days prior to the first dose of study treatment, except for intranasal, inhaled, topical, or locally injected (e.g., intraarticular injection) steroids
  • History of serious gastrointestinal bleedings within 12 weeks prior to screening or presence of diseases that may affect oral drug absorption (e.g., malabsorption syndrome, active peptic ulcer)
  • History of human immunodeficiency virus infection or active hepatitis B or C infection or ongoing uncontrolled chronic infectious disease
  • Pregnant or lactating women or patients planning to become pregnant during the study
  • Participation in another clinical trial within 30 days prior to screening
  • Individual considered ineligible 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03317743
Other Study ID Numbers  ICMJE NOV140101-101/ID-VDP-101
Has Data Monitoring Committee Not Provided
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 Idience Co., Ltd.
Study Sponsor  ICMJE Idience Co., Ltd.
Collaborators  ICMJE
  • IlDong Pharmaceutical Co Ltd
  • National OncoVenture
Investigators  ICMJE Not Provided
PRS Account Idience Co., Ltd.
Verification Date January 2021

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