EUCTR2016-001468-12-GB进行中（未招募）1 期
A Phase 1/2a, open-label multicenter study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PEN-221 in patients with somatostatin receptor 2 expressing advanced cancers, including gastroenteropancreatic or lung or thymus or other neuroendocrine tumors or small cell lung cancer or large cell neuroendocrine carcinoma of the lung - Phase 1/2a to assess PEN-221 in somatostatin receptor 2 expressing advanced cancers
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •All patients must meet all of the following criteria to be eligible to participate:
- •1.Provision and understanding of signed and dated, written informed consent prior to any mandatory study-specific procedures, sampling, analysis.
- •2.Male or female aged = 18 years.
- •3.ECOG PS of 0 – 1.
- •4.Adequate organ function within 14 days before C1D1, defined as follows:
- •Bone marrow: Absolute neutrophil count (ANC) = 1.5x109/L, platelet count = 100x109/L, and hemoglobin = 9 g/dl
- •Hepatic: total bilirubin = 1.5× the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5× ULN
- •Renal: If serum creatinine concentration = 1.5× ULN, then estimated creatinine clearance must be = 50 mL/min (Cockroft-Gault formula).
- •5.Serum potassium, calcium, magnesium and phosphorus within normal limits. If values are low on the initial screening assessment, supplements may be given and values repeated to confirm within normal limits.
- •6.If a female of childbearing potential, negative serum pregnancy test within 3 days before C1D1, or in the event of a positive serum pregnancy test, exclusion of pregnancy as assessed by transvaginal ultrasound overseen by a health care professional with experience in investigating and diagnosing early pregnancy, as human chorionic gonadotropin (HCG) can be secreted by neuroendocrine tumor. A female of childbearing potential must agree to the use of highly reliable, physician-approved contraception from 14 days before C1D1 through 3 months after the last study drug dose. Highly reliable contraception means 2 of the following: (1) established use of oral, injected, or implanted hormonal methods of contraception, (2) placement of an intrauterine device, (3) condom or occlusive cap (diaphragm or cervical vault cap with spermicidal gel, foam, film, cream, or vaginal suppository), (4) male sterilization with verified absence of sperm in ejaculate post-vasectomy. Alternatively, true abstinence is acceptable when it is the preferred and usual lifestyle of the individual. Calendar, symptothermal, post-ovulation, coitus interruptus, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.
- •7.If male, is surgically sterile or agrees to use a condom from C1D1 through 3 months after the last study drug dose. Alternatively, true abstinence is acceptable when it is the preferred and usual lifestyle of the individual.
- •8.SSTR2 positive tumor as assessed using a SARI agent and as defined as follows:
- •For SCLC patients, tumor uptake equal to or greater than liver uptake
- •For all other patients, tumor uptake greater than liver uptake. SARI performed during the Pre-screening phase must be an agent that is approved for use by the regional regulatory authority. Documented results of SARI performed as part of a patient’s routine diagnostic assessments prior to the Pre-screening phase and within 180 days of C1D1 may be used in place of a Pre-screening phase SARI assessment.
- •9.Patients in Phase 1 must have a histologically- or cytologically-confirmed solid tumor in 1 of the following categories listed in the protocol after 1 or more prior lines of anticancer therapy, unless no standard treatments are available or unless such treatments
排除标准
- •Patients meeting any of the following criteria are not eligible for study participation:
- •1.Treatment with anticancer therapy (as defined in inclusion criterion 9) or an investigational drug or device within 3 weeks (6 weeks for mitomycin C and nitrosoureas) or 5 half-lives of the agent (whichever is shorter) before C1D1. In addition, any drug-related toxicity, with the exception of alopecia, must have recovered to = Grade 1.
- •2.Any other malignancy known to be active or treated within 3 years of the start of screening, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
- •3.One or more of the following cardiac criteria:
- •Unstable angina
- •Myocardial infarction within 6 months prior to screening
- •New York Heart Association Class II – IV heart failure
- •Corrected QT interval (QTc) > 470 msec obtained as the mean from 3 consecutive resting ECGs using the Fredericia formula
- •Clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block)
- •Congenital long QT syndrome
- •Symptomatic orthostatic hypotension within 6 months prior to screening
- •Uncontrolled hypertension.
- •4.Stroke or transient ischemic attack within 6 month prior to screening.
- •5.Grade >1 peripheral neuropathy.
- •6.Patient requires medication with a strong CYP3A4 inhibitor, e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole.
- •7.History of leptomeningeal disease or spinal cord compression.
- •8.Brain metastases unless asymptomatic on a stable low dose of steroids.
- •Patients with SCLC or LCNEC of the lung only: CT or MRI of the brain required during screening. If positive for brain metastases, patients must have undergone radiotherapy prior to initiating treatment with PEN-221. If whole brain radiotherapy is performed, a 14-day washout is required prior to treatment with PEN-221. If stereotactic radiosurgery or stereotactic radiotherapy is performed, a 7-day washout prior to treatment with PEN-221 is required.
- •9.Major surgery within 28 days prior to C1D1.
- •10.Female who is pregnant or breast-feeding.
- •11.As judged by Investigator, evidence of severe or uncontrolled systemic disease, active bleeding diatheses, renal or liver transplant, or active infection including known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- •12.Hypersensitivity or history of anaphylactic reaction to octreotide or other somatostatin analogs.
- •13.Hypersensitivity or history of anaphylactic reaction to maytansinoids or their derivatives.
- •14.Any medical, psychological, or social condition that would interfere with the patient’s participation in the study.
研究者
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