Dose-Escalation and Safety Trial of YN968D1

Completed · Phase 1/Phase 2

Conditions studied: Cancer Patients With Solid Tumors

In brief

This protocol will be divided into two parts: Part 1 will evaluate the safety and pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day continuous course of therapy; Part 2 will evaluate the safety and preliminary efficacy in an open-label administration of YN968D1 at the MTD or a maximum of 750 mg. All subjects in Part 1 and Part 2 of this study will be permitted to continue therapy with only safety monitoring and bimonthly assessments for progression, if the product is well tolerated and the subject has stable disease or better. Up to 72 subjects will be enrolled in this clinical trial.

Key facts

Study ID

NCT01497704

Run by

Elevar Therapeutics

People needed

55

Starts

2012-04-01

Expected to finish

2015-05-01

Last updated by the study team

2017-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• 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
• Evaluable disease defined by RECIST 1.1 as measured by a suitable imaging technique
• Life expectancy ≥ 3 months
• Subject must be suitable for oral administration of study medication
• Signed written informed consent
• 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
• ECOG performance status ≤ 2
• 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
• 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
• Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures

You may not qualify if…

• Pregnant or lactating women
• 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.
• Hemoptysis within 3 months prior to first scheduled dose of YN968D1
• Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) prior to first scheduled dose of YN968D1
• Surgery or visceral (e.g., hepatic or renal) biopsy within 28 days prior to first scheduled dose of YN968D1
• Minor surgical procedure performed within 7 days prior to first scheduled dose of YN968D1
• Prior exposure to YN968D1 (prior treatment with an angiogenesis inhibitor is not exclusionary)
• Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19.
• Known history of human immunodeficiency virus infection (HIV)
• Subjects with active bacterial infections and/or receiving systemic antibiotics
• Current or past diagnosis of leukemia within the past 5 years
• Prior radiotherapy at the target lesion
• Known CNS metastases or clinical evidence of CNS involvement that is not stable for last 3 months by radiology documentation
• Medical history of non-healing wound within past 2 weeks
• History of bleeding diathesis or bleeding within 14 days prior to enrollment
• 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
• 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
• History of idiopathic or hereditary angioedema
• History of sickle cell or any hemolytic anemia
• 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
• Complete left bundle branch block (LBBB), bifascicular block (RBBB with either left anterior hemiblock or left posterior hemiblock)
• Any clinically significant ST segment and/or T-wave abnormalities
• 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
• Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication
• Congestive heart failure (New York Heart Association class III-IV)

Where it is running

• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• ASAN Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.