A Phase 1b/2a Three-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination with Gemcitabine in Patients with Advanced or Metastatic Cancer with a Focus on Ovarian Cancer - ESPS-001(m)

Esperas Pharma Inc.0 个研究点目标入组 25 人开始时间: 2023年5月2日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Esperas Pharma Inc.
入组人数: 25

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

年龄范围: 18 至 65+（—）

入选标准

•Ambulatory patients = 18 years of age, Have given written informed consent prior to any study-specific procedures, Are reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures, Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, Have an estimated life expectancy of =12 weeks, Are able to swallow capsules, Have adequate organ function including: a) Hematologic: ANC =1.5 x 109/L, platelets =100 x 109/L, and hemoglobin = 90 g/L. Patients may receive red blood cell transfusions to achieve this hemoglobin level at the discretion of the investigator, so long as transfusions are discontinued ?7 days prior to initiation of study treatments. b) Hepatic: Bilirubin =1.5 times ULN, ALT and AST =2.5 times ULN. If the liver has tumor involvement, AST and ALT equaling =5 times ULN are acceptable. c) Renal: Estimated glomerular filtration rate (eGFR) =60 mL/min/1.73 m2, Have discontinued cytotoxic therapy, biologic therapy, immunotherapy, and cancer-related hormonal therapy at least 21 days prior to study enrollment (6 weeks for mitomycin-C or nitrosoureas), and have discontinued radiotherapy at least 21 days prior to study enrollment, Have discontinued drugs with moderate inhibition of CYP2D6 or greater at least 5 half-lives prior to study enrollment, Are recovered or recovering from the acute adverse effects of any chemotherapy, biologic therapy, immunotherapy, cancer-related hormonal therapy, therapy with investigative agents, or radiotherapy (=Grade 1), with the exception of Grade 2 alopecia or neuropathy, Have received at least 2 but no more than 4 prior systemic therapies for locally advanced or metastatic disease (e.g., hormonal, cytotoxic, etc.), at least one of which should be platinum-based., Patients who have had major surgery must be fully recovered and =4 weeks postoperative prior to enrolling on study, Males and females with reproductive potential must agree to use highly effective, medically approved contraceptives and females must avoid egg cell donation during the study and for 6 months following the last dose of study treatment. Highly effective contraceptives for females includes: – combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal – progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable – intrauterine device – intrauterine hormone-releasing system – bilateral tubal occlusion – vasectomised partner –sexual abstinence, All females of child-bearing potential females must have had a negative serum pregnancy test result = 28 days prior to the first dose of study treatment and must have had a negative urine pregnancy test result =1 day prior to the first dose of study treatment. For the purpose of this document, a female is considered of childbearing potential i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause., Patients must have documented progressive disease after the last treatment regimen and tumor lesions that are considered measurable by RECIST v1.1. Lesion(s) must be accurately measurable in at least one dimension, and for which

排除标准

•Have received treatment with an investigational drug which has not received regulatory approval for any indication within 21 days of study treatment with LY, Have QTcB >470 msec (female) or >450 msec (male), a history of congenital long QT syndrome, or other conduction abnormality that in the opinion of the investigator would preclude safe participation in this study, Have had an autologous or allogeneic bone marrow transplant, Are currently enrolled in another clinical study of an investigational medicinal product, Have hypersensitivity to the active substance of gemcitabine or to any of its excipients, Have already participated in this study, Have had radiation therapy to >25% of bone marrow, For Parts B and C, patients who have a history of another active cancer within the past year except cervical cancer in situ, in situ carcinoma of the bladder, basal cell carcinoma of the skin or another in situ carcinoma that is considered cured by the investigator, Have medical conditions that, in the opinion of the investigator, would preclude participation in this study (e.g., a new or preexisting skin disorder that would make IV administration and/or toxicity assessments difficult), Have symptomatic central nervous system (CNS) metastasis. Patients with treated CNS metastasis are eligible, provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic patients without a history of CNS metastasis is not required, Have a history of major organ transplant (e.g., heart, lungs, liver, and kidney), Females who are pregnant or nursing, Have known positive test results of human immunodeficiency virus, or have chronic active hepatitis A, B or C.

研究者

发起方

Esperas Pharma Inc.

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