临床试验/NCT00336986

NCT00336986已完成2 期

An Open-label, Dose Escalation Safety and Tolerability Study of Recombinant Human Interleukin-21 (Phase 1) Followed by an Open-label Treatment Study (Phase 2a) in Patients With Stage IV Malignant Melanoma

Novo Nordisk A/S8 个研究点分布在 1 个国家目标入组 54 人开始时间: 2004年9月最近更新: 2023年8月14日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 54
试验地点: 8
主要终点: Tumor size assessed according to international criteria

研究概览研究设计入排标准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 trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At least 14 to a maximum of 40 patients, who have not previously received treatment for their stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.

研究设计

研究类型: Interventional
分配方式: Non Randomized
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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically confirmed surgically incurable metastatic melanoma
•Patients must have measurable disease
•ECOG performance status of 0 or 1
•Expected life expectancy at least 4 months

排除标准

•History of and signs/symptoms of uncontrolled brain metastases or edema.
•Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.)
•Radiotherapy: Radiation therapy within 4 weeks prior to entering the study.
•Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.

结局指标

主要结局

Tumor size assessed according to international criteria

时间窗: After 8 weeks

次要结局

Serum levels of antibodies against recombinant human IL-21.
Markers of immunomodulation in blood.
Safety evaluation.
Time to progression.

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (8)

Loading locations...

相似试验

招募中

1 期

H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLCNon-small Cell Lung Cancer

NCT05552781RedCloud Bio76

招募中

1 期

Phase I/IIa Study of H002 in NSCLC With Active EGFR MutationNon-small Cell Lung Cancer

NCT05519293RedCloud Bio76

已完成

1 期

Gene Therapy Study in Severe Haemophilia A Patients (270-201)Severe Haemophilia A

NCT02576795BioMarin Pharmaceutical15

已完成

2 期

Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell CarcinomaBasal Cell Carcinoma

NCT04669808Sirnaomics32

招募中

1 期

A Study of Oral Nuvisertib (TP-3654) in Patients With MyelofibrosisMyelofibrosis

NCT04176198Sumitomo Pharma America, Inc.240