临床试验/NCT04860700

NCT04860700已完成2 期

A Phase 2 Study of Anlotinib in Patients With Metastatic Pheochromocytoma or Paraganglioma

Peking Union Medical College Hospital1 个研究点分布在 1 个国家目标入组 27 人开始时间: 2021年4月30日最近更新: 2024年6月12日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Peking Union Medical College Hospital
入组人数: 27
试验地点: 1
主要终点: Objective Response rate RECIST Using Version 1.1

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This phase II trial studies how well anlotinib hydrochloride works in treating patients with metastatic pheochromocytoma or paraganglioma. Anlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

详细描述

PRIMARY OBJECTIVES:

To determine the anti-tumor activity of anlotinib hydrochloride (Objective Response rate,ORR) in patients with metastatic pheochromocytomas or paragangliomas.

SECONDARY OBJECTIVES:

I. To assess safety profile of anlotinib. II. To assess progression-free survival time. III. To assess disease control rate.

OUTLINE:

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Provide written informed consent.
•Willing to return to enrolling institution for follow-up.
•Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or
•Life expectancy > 3 months.
•Patients diagnosis with metastatic pheochromocytoma or paraganglioma that is unresectable.
•Laboratory requirements:
•1）Absolute granulocyte count (AGC) greater than 1.5 x 109/L; 2）Platelet count greater than 80 x 109/L; 3) Hemoglobin greater than 90g/L; 4) Serum bilirubin less than 1.5 x upper limit of normal (ULN); 5)Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN; 6) Serum creatinine less than 1.5 x ULN or creatinine clearance (CCr)≥60ml/min; 7.Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).

排除标准

•Any of the following:Pregnant women,Nursing women,Men or women of childbearing potential who are unwilling to employ adequate contraception.
•Patients who have previously used other anti-vascular targeted drugs, such as sunitinib, bevacizumab, endurance, etc.
•Chemotherapy/systemic therapy, radiotherapy, immunotherapy or surgery within 4 weeks prior to kinase inhibitor therapy.
•Patients with another primary malignancy within 5 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer).
•Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.).
•Patients with known untreated brain metastases are excluded. Patients having a history of brain metastasis that have been previously irradiated or resected greater than 2 months prior to enrollment and are clinically and radiographically stable will be considered for enrollment. Patients with brain metastases with symptoms or symptom control for less than 2 months.
•Active or uncontrolled intercurrent illness including, but not limited to 1)Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); 2) Patients with uncontrolled myocardial ischemia or myocardial infarction, arrhythmia (including QTC≥480ms), and uncontrolled congestive heart failure，grade ≥2（New York Heart Association ）; 3) ongoing or active infection; 4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; 5) Renal failure requires hemodialysis or peritoneal dialysis; 6) Have a history of immunodeficiency, including HIV or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7) Diabetes is poorly controlled (fasting blood glucose (FBG)> 10mmol/L); 8) Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein content is confirmed to be greater than 1.0 g; 9) Patients who have seizures and need treatment;
•Any of the following conditions =< 6 months prior to registration: Cerebrovascular accident (CVA) or transient ischemic attack (TIA); Serious or unstable cardiac arrhythmia; Pulmonary embolism, untreated deep venous thrombosis (DVT).
•Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment.
•Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders.
•Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
•Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before enrollment, patients with any bleeding or bleeding event ≥ CTCAE grade 3, unhealed wounds, ulcers or fractures.
•Participated in other clinical trials within 4 weeks.
•Patients are using drugs that interact with Anlotinib.

研究组 & 干预措施

anlotinib hydrochloride

Experimental

Patients receive anlotinib hydrochloride 12mg orally once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

干预措施: anlotinib hydrochloride (Drug)

结局指标

主要结局

Objective Response rate RECIST Using Version 1.1

时间窗: minimum of 4 cycles

Defined for all patients whose tumor met the criteria of Complete Response (CR)and Partial Response (PR)

次要结局

Disease Control Rate(minimum of 4 cycles)

研究者

发起方

Peking Union Medical College Hospital

申办方类型

Other

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

已完成

2 期

Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney CancerRecurrent Renal Cell CancerStage IV Renal Cell CancerClear Cell Renal Cell Carcinoma

NCT00408902National Cancer Institute (NCI)10

已完成

2 期

A Phase 2 Trial of Ponatinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal TumorGIST

NCT01874665Ariad Pharmaceuticals45

已完成

2 期

NCT00114283National Cancer Institute (NCI)30

已完成

2 期

Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT.Malignant Neoplasm

NCT02272998Sameek Roychowdhury22

已完成

2 期

S0331: Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Merkel Cell CancerRecurrent Neuroendocrine Carcinoma of the SkinStage II Neuroendocrine Carcinoma of the SkinStage III Neuroendocrine Carcinoma of the Skin

NCT00068783National Cancer Institute (NCI)40