A Phase II Clinical Study to evaluate the efficacy and safety of NRC-AN-019 in cancer patients failing prior standard therapies

ATCO Pharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1. Histologically or cytologically confirmed metastatic or locally advanced or inoperable Pancreatic Cancer, Non-Small Cell Lung Cancer (NSCLC), Breast Cancer, Glioma, Colorectal Cancer, Ovarian Cancer and Head & Neck Cancer. Imatinib resistant and/or intolerant in case of GIST and CML
•2. Male and female patients with age between 18 and 65 years
•3. Must not have received chemotherapy or irradiation or any other investigational product within 14 days of entry to the trial
•4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•5. Patients must have measurable lesion, defined as that can be measured in at least one dimension (longer diameter)
•>=20 mm with conventional technique (CT/MRI) or as >= 10 mm with spiral CT
•6. Patients with a probable minimum life expectancy >= 6 months
•7. Must have adequate organ and marrow function
•8. Renal function (normal serum creatinine and blood urea nitrogen)
•9. Liver function (total bilirubin level <=2 times upper normal limit (UNL) and serum transaminases levels <= 2.5 times UNL. <= 5 times for liver metastasis and/or obstructive jaundice).
•10. WBC at least 3,000/mm3, neutrophil count >=2000/mm3, platelet count >= 1,00,000.mm3 and hemoglobin level 8.0 g/dL

•1. The patient has not recovered from clinically-meaningful toxicity due to prior therapy (i.e., back to baseline or Grade less than or equal to 1), with the exception of neurotoxicity and alopecia
•2. The patient has uncontrolled intercurrent illness including ongoing or active infection, diabetes mellitus, hypertension, symptomatic congestive cardiac failure, unstable angina pectoris, stroke or myocardial infarction within 3 months.
•3. The patient is either pregnant or lactating
•4. Patients who have tested positive to HIV or HBsAG or HCV
•5. Patients with brain metastasis

发起方

ATCO Pharma Limited