Status:
COMPLETED
Study to Assess the Safety & Tolerability of NOV140101(IDX-1197) in Patients With Advanced Solid Tumors
Lead Sponsor:
Idience Co., Ltd.
Collaborating Sponsors:
IlDong Pharmaceutical Co Ltd
National OncoVenture
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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...
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 patient...
Eligibility Criteria
Inclusion
- ≥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:
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0g/dL
- Serum creatinine ≤ 1.5×ULN
- Total bilirubin ≤ 1.5×ULN
- AST, ALT ≤ 3×ULN (≤ 5×ULN for patients with liver metastasis or liver cell cancer)
- PT and aPTT ≤ 1.5×ULN
- 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
- 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
Key Trial Info
Start Date :
August 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03317743
Start Date
August 29 2017
End Date
October 13 2021
Last Update
February 3 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, Songpa-gu, South Korea, 05505