Phase I trial of AXL1717, an orally bioavailable anti cancer drug, in patients with solid tumors. - AXL1717

Cadila Pharmaceuticals Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Cadila Pharmaceuticals Limited

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1.Male/female Patients above the age of 18 years with Histologic or cytologic diagnosis of a solid tumor (preferably NSCLC - squamous or non-squamous) except cancers of the intestinal tract (gastric, colon, rectal, and pancreatic cancer).
•2.Patients must have advanced disease and deemed refractory to standard anti-cancer therapy or are not expected to benefit or prolong survival from any standard anti-cancer therapy.
•3.Royal Marsden Hospital score of (<= 2).
•4.ECOG performance status <= 2.
•5.Patients have adequate bone marrow, kidney, liver, heart and lung function without clinical significant laboratory parameters as per below criteria:
•Hb >= 9.0 g/dL;
•Leukocyte count (>= 3.0 X 109/L),
•Neutrophil count (>= 1.5 X 109/L),
•Platelet count (>= 75 X 109/L),
•Total bilirubin (>= 1.5 times the upper institutional limit of the normal range),
•Liver transaminases (P-AST or P-ALT <= 2.5 times upper institutional limit of the normal range; <= 5 times if liver metastases have been documented),
•Alkaline phosphatase <= 2.5 x ULN and <= 5 if documented liver metastasis.
•Plasma creatinine (<= 1.5 times upper institutional limit of the normal range),
•12-lead ECG with normal tracings.
•6.Fully recovered from any previous surgery (at least 4 weeks since major surgery).
•7.Fully recovered from previous radiation therapy (at least 4 weeks).
•8.Use of reliable forms of contraception in women of childbearing potential must [i.e., abstinence, spermicides, condoms, or other reliable forms of contraception other than oral contraceptives].
•9.All subjects must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential.
•10.Patient capable of providing informed consent and compliance to follow study related procedure.

排除标准

•1.Concurrent cancer chemotherapy, biologic therapy or radiotherapy.
•2.No prior anti-cancer therapies within 4 weeks and recovered from toxicities due to prior anti-cancer therapy,
•3.Use of potent inhibitors of CYP2C9 from 3 weeks to first administration of IP.
•4.Concurrent treatment with CYP3A4 inhibitors.
•5.Administration of any investigational agent within 28 days prior to current therapy.
•6.Brain or leptomeningeal metastases, Tumors invading or abutting major blood vessels.
•7. >=grade 2 diarrhoea or constipation within 14 days, bowel obstruction or motility disorders which influence drug absorption.
•8.Concomitant severe or uncontrolled underlying medical disease unrelated to the tumour, psychiatric disorder.
•9.Positive serology for HIV or active, known hepatitis B or C, HCV & HBsAg.
•10.Unstable systemic disease (including active infection, uncontrolled HT, unstable angina, CHF, MI, cardiac arrhythmia, hepatic, renal or metabolic disease).
•11.Female: pregnant, nursing an infant or planning pregnancy throughout the study, women of childbearing potential must use reliable forms of contraception.
•12.Any condition in opinion of investigator may put patient at significant risk, confound results or interfere significantly with participation.
•13.Participation in clinical study within 30 days prior to entering the study.

研究者

发起方

Cadila Pharmaceuticals Limited

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