Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT01497704
Eligibility Criteria:
Inclusion Criteria:
1. 18 years of age or older
2. Subjects may be enrolled with the following malignancies:
* Part 1: Subjects with any solid malignant tumor that are refractory to conventional therapy or the subject does not tolerate the conventional therapy
* Part 2: Subjects diagnosed with NSCLC, CRC, RCC, Gastric cancer, GIST or triple negative Breast Cancer that are refractory to conventional therapy or the subject does not tolerate the conventional therapy
3. Evaluable disease defined by RECIST 1.1 as measured by a suitable imaging technique
4. Life expectancy ≥ 3 months
5. Subject must be suitable for oral administration of study medication
6. Signed written informed consent
7. Adequate bone marrow, renal, and liver function as manifested by the following:
* CBC: ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9.0 g/dL
* CMP: Creatinine clearance \> 50 mL/min or serum creatinine \< 1.5 x ULN, serum bilirubin \< 2.5 x ULN, AST and ALT ≤ 5.0 × ULN
* Coagulation profile with PT and INR, each ≤ 1.5 x ULN
* Proteinuria \< 200 mg by 24- hour urine collection without evidence of active sediment or hematuria
8. ECOG performance status ≤ 2
9. Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of YN968D1 until 4 weeks after discontinuing study drug and male subjects must agree to use contraceptive measures during the study and ending 4 weeks after last dose of study drug
10. Female patients of child-bearing potential are confirmed to have either a negative serum ß-hCG test, or have been evaluated by a gynecologist to confirm the patient is not pregnant, within 7 days prior to administration of initial dose of YN968D1
11. Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures
Exclusion Criteria:
1. Pregnant or lactating women
2. Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to first scheduled dose of YN968D1 that may prevent clotting and in the opinion of the investigator would place the subject at risk.
3. Hemoptysis within 3 months prior to first scheduled dose of YN968D1
4. Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) prior to first scheduled dose of YN968D1
5. Surgery or visceral (e.g., hepatic or renal) biopsy within 28 days prior to first scheduled dose of YN968D1
6. Minor surgical procedure performed within 7 days prior to first scheduled dose of YN968D1
7. Prior exposure to YN968D1 (prior treatment with an angiogenesis inhibitor is not exclusionary)
8. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19.
9. Known history of human immunodeficiency virus infection (HIV)
10. Subjects with active bacterial infections and/or receiving systemic antibiotics
11. Current or past diagnosis of leukemia within the past 5 years
12. Prior radiotherapy at the target lesion
13. Known CNS metastases or clinical evidence of CNS involvement that is not stable for last 3 months by radiology documentation
14. Medical history of non-healing wound within past 2 weeks
15. History of bleeding diathesis or bleeding within 14 days prior to enrollment
16. Medical history of clinically significant thrombosis (bleeding or clotting disorder) within the past 3-months that in the opinion of the investigator may place the patient at risk of side effects on an anti-angiogenesis product
17. History of non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months that in the opinion of the investigator may place the patient at risk of side effects on an anti-angiogenesis product
18. History of idiopathic or hereditary angioedema
19. History of sickle cell or any hemolytic anemia
20. History of uncontrolled hypertension that in the opinion of the investigator is not well managed by medication and may place the patient at risk when taking a VEGF inhibitor
21. Complete left bundle branch block (LBBB), bifascicular block (RBBB with either left anterior hemiblock or left posterior hemiblock)
22. Any clinically significant ST segment and/or T-wave abnormalities
23. Presence of unstable atrial fibrillation (ventricular response rate \> 100 bpm). Patients with stable atrial fibrillation are allowed in the study provided they do not meet another exclusion criteria
24. Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication
25. Congestive heart failure (New York Heart Association class III-IV)
26. History of other significant cardiovascular disease or vesicular disease within the last 6 months (e.g. such as hypertensive crisis, hypertensive encephalopathy, stroke or TIA, or significant peripheral vascular disease) that in the opinion of the investigator may place the patient at risk when taking a VEGF inhibitor
27. History of significant gastrointestinal disorders that in the opinion of the investigator may place the patient at risk when taking a VEGF inhibitor; such as an abdominal fistula, GI perforation, or bleeding ulcer within 2 months of treatment
28. QTcF \>450 msec on screening ECG
29. Baseline echocardiogram (within 2 months) with left ventricular ejection fraction (LVEF) \<50%
30. History of clinically significant glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies
31. History of myocardial infarction within the past 6 months
32. Treatment with an investigational agent within the longest time frame of either 5 half-lives or 30 days of initiating study drug
33. Medical or psychiatric illness that, in the opinion of the Investigator, may impact the safety of the subject or objectives of the study
34. Known recreational substance use or psychiatric illness that, in the opinion of the Investigator, may affect compliance with scheduled visits
35. Known hypersensitivity to YN968D1 or components of the formulation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01497704
Study Brief:
Protocol Section:
NCT01497704