EUCTR2016-002522-36-ES进行中（未招募）1 期
An open label phase II study to evaluate the efficacy and safety of PDR001 in patients with advanced or metastatic non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin who have progressed on prior treatment
ovartis Farmacéutica, S.A.0 个研究点目标入组 90 人开始时间: 2016年12月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- 性别
- All
入选标准
- •1. Written informed consent must be obtained prior to any screening procedures
- •2. Adult males or females = 18 years at screening.
- •3. Pathologically confirmed, well-differentiated (G1 or G2) based on local pathologist report,
- •advanced (unresectable or metastatic), non-functional neuroendocrine tumor of GI,
- •pancreatic or thoracic (including lung and thymus) origin.
- •4. No history of, and no active symptoms related to carcinoid syndrome.
- •5. Patients must have received prior treatment for advanced disease:
- •? Thoracic (lung and thymus origin) cohort:
- •? Thymus origin: at least one prior systemic therapy according to investigator’s
- •? Lung origin: at least one prior systemic therapy is required, which must include
- •everolimus.
- •? GI cohort: at least two prior systemic regimens, which must include everolimus. Prior
- •systemic therapies may include: somatostatin analogs, PRRT, and chemotherapy
- •? pNET cohort: at least two prior systemic regimens, which must include everolimus or
- •sunitinib. Prior systemic therapies may include: somatostatin analogs, PRRT, and
- •chemotherapy
- •Note: Prior treatment with interferon alpha is allowed provide that it is not the last
- •treatment received prior to study entry
- •6. Radiological documentation of disease progression while on/or after the last treatment,
- •and this progression must have been observed within 6 months prior to start of study
- •treatment (i.e. maximum of 24 weeks from documentation of progression until study
- •entry). Disease must show evidence of radiological disease progression based on scans
- •performed not more than one year apart.
- •7. At least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
- •Note: Any lesions which have been subjected to percutaneous therapies or radiotherapy
- •should not be considered measurable, unless the lesion has clearly progressed since the
- •8. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- •9. Patients must be willing to provide biopsy material for the purpose of biomarker analysis
- •that was collected following the diagnosis of metastatic disease. The tumor sample must
- •be collected from a metastatic site not previously irradiated and should preferably be
- •taken within 6 months but not more than 1 year prior to start of study treatment.
- •10. Women of childbearing potential must have had a negative serum pregnancy test within
- •72 hours prior to the start of study treatment. Highly effective contraception must be used
- •while on study.
- •11. Patient is deemed by the investigator to have the ability and means to be compliant with
- •the protocol (treatment and follow-up).
- •12. Patient must meet the following laboratory values at the screening visit:
- •? Absolute Neutrophil Count =1.5 x 109/L
- •? Platelets =75 x 109/L
- •? Hemoglobin (Hgb) =9 g/dL
- •? Serum creatinine <1.5 mg/dL
- •? Total bilirubin =1.5 x ULN
- •? Aspartate transaminase (AST) = 3.0 x ULN, except for patients with liver metastasis,
- •if AST =5.0 x ULN
- •? Alanine transaminase (ALT) = 3.0 x ULN, except for patients with liver metastasis, if
- •ALT =5.0 x ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- 另有 2 项未显示
排除标准
- •1. Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
- •adenocarcinoid, goblet cell carcinoid, large cell neuroendocrine carcinoma and small cell
- •2. Pretreatwith interferon as last treatment prior to start of study treatment
- •3. Prior treatment for study indication
- •4. Systemic chronic steroid therapy (= 10mg/day prednisone or equivalent) or any
- •immunosuppressive therapy 7 days prior to planned date for first dose of study treatment.
- •5. Any untreated central nervous system (CNS) lesion.
- •6. Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF, M-CSF),
- •thrombopoietin mimetics or erythroid stimulating agents = 2 weeks prior to the first dose
- •of study treatment.
- •7. Malignant disease, other than that being treated in this study.
- •8. Major surgery, open biopsy, or significant traumatic injury within 2 weeks prior to start of
- •study treatment.
- •9. Anticipation of the need for major surgical procedure during the course of the study
- •10. Radiation therapy within 4 weeks prior to start of study treatment
- •11. Hepatic intra-arterial embolization within the last 6 months.
- •12. History of severe hypersensitivity reactions to other monoclonal antibodies
- •13. Impaired cardiac function or clinically significant cardiac disease, including any of the
- •14. Active, known or suspected autoimmune disease or a documented history of autoimmune
- •disease, including ulcerative colitis and Crohn’s disease
- •15. Active infection requiring systemic antibiotic therapy.
- •16. Known history of testing positive for Human Immunodeficiency Virus (HIV) infection.
- •17. Patients with active Hepatitis B infection (HBsAg positive) will be excluded.
- •18. Patients with positive test for hepatitis C ribonucleic acid (HCV RNA)..
- •19. Any medical condition that would, in the investigator’s judgment, prevent the patient’s
- •participation in the clinical study due to safety concerns, compliance with clinical study
- •procedures or interpretation of study results.
- •20. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study
- •21. Presence of = CTCAE grade 2 toxicity (except alopecia, peripheral neuropathy, and
- •ototoxicity, which are exclusion criteria if = CTCAE grade 3) due to prior cancer therapy.
- •22. Not able to understand and to comply with study instructions and requirements.
- •23. Pregnant or nursing (lactating) women confirmed by a positive hCG laboratory test within
- •72 hours prior to initiating study treatment. Note: Low levels of hCG may also be
- •considered a tumor marker, therefore if low hCG levels are detected, another blood sample
- •at least 4 days later must be taken to assess the kinetics of the increase and transvaginal
- •ultrasound must be performed to rule out pregnancy.
- •24. Women of child-bearing potential, defined as all women physiologically capable of
- •becoming pregnant, unless they are using highly effective methods of contraception
- •during dosing and for 150 days after stopping treatment with PDR001. Highly effective
- •contraception methods include:
- •a. Total abstinence (when this is in line with the preferred and usual lifestyle of the
- •patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
- •methods) and withdrawal are not acceptable methods of contraception
- •b. Female sterilization (have had surgical bilateral oophorectomy with or without
- •hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking
- •study treatment
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