A Phase I Dose Escalation Study of MK2461 in Patients With Advanced Cancer

Merck Sharp & Dohme LLC0 个研究点目标入组 25 人开始时间: 2007年2月最近更新: 2015年3月27日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 25
主要终点: To evaluate the safety and tolerability of MK2461

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.

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

•Patients must be at least 18 years of age, with adequate organ function, and an ECOG performance of <2
•Patients must be willing to undergo pre-study and post dose tumor biopsy and have tumor accessible to biopsy (waived during Part A)

排除标准

•No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation
•Patients must not have primary central nervous system tumor
•Patient has had prescription or non-prescription drugs or other products known to be metabolized by CYP3A4 that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication

结局指标

主要结局

To evaluate the safety and tolerability of MK2461

时间窗: 18 Months

次要结局

To determine the Recommend Phase II Dose or doses (RP2D) based on safety, tumor pharmacodynamics, and parmacokinetics.(18 Months)

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

1 期

A Study of MK-8033 in Patients With Advanced Solid Tumors (MK-8033-001)Advanced Cancer

NCT00559182Merck Sharp & Dohme LLC47

已完成

1 期

Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)NeoplasmsMalignant

NCT00880568Merck Sharp & Dohme LLC27

已完成

1 期

A Study of JNJ-63898081 in Participants With Advanced Stage Solid TumorsNeoplasms

NCT03926013Janssen Research & Development, LLC40

招募中

1 期

A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid Tumors

NCT06248411Kyowa Kirin Co., Ltd.189

Unknown

1 期

A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549Advanced Solid Tumors (Part A/B/C/D)Non-small Cell Lung Cancer (Part E)Melanoma (Part E)Squamous Cell Cancer of the Head and Neck (Part E)Triple Negative Breast Cancer (Part F)Adrenocortical Carcinoma (Part G)Mesothelioma (Part G)High-circulating Myeloid-derived Suppressor Cells (Part H)

NCT02637531Infinity Pharmaceuticals, Inc.219