A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 22
- 主要终点
- Part 1: Determine the maximum tolerated dose (MTD)
研究概览
简要总结
The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are:
- Does CP-383 slow or stop the growth of cancer in patients with advanced cancer
- What medical problems do participants have when taking CP-383 Researchers will test CP-383 in all kinds of cancers at various dose levels to determine what the best dose is to study further. Researchers will also see if certain cancers that have gene mutations respond better to CP-383
Participants will:
- Take CP-383 every day by mouth until the researcher learns whether CP-383 is helping slow or reduce the cancer growth
- Visit the clinic weekly for the first 6 weeks for checkups and tests
- Visit the clinic every 3 weeks thereafter for checkups and tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Measurable or non measurable cancer that the research can assess for changes
- •Not eligible or able to take existing standard therapies for cancer
- •Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor
- •Diagnosed with locally advanced, recurrent or metastatic incurable disease
- •Part 1: any solid tumor (with the exception of brain cancer) that has progressed, standard therapy is no longer or has not helped the cancer, or is too toxic and for whom a clinical trial is an option for continued treatment
- •Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer - some of these will have a specific gene mutation in the cancer
- •Part 1: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer
- •Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer - some of these will have a specific gene mutation in the cancer
- •_ Part 2: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer
- •Adequate blood and urine lab tests
- •Women and men of childbearing potential with adequate contraception
- •Provides written informed consent
- •Willing to comply with the requirements of the protocol
排除标准
- •Inability to swallow pills
- •Known history of HIV, HCV, HBV unless cured, controlled with undetectable viral load
- •Active tumor in the brain
- •Clinically significant liver disease
- •Significant gastrointestinal diseases
- •History of other cancer within past 5 years with certain exceptions for cancers that are likely cured
- •Significant cardiac disease
- •Other diseases that are not well controlled that could make taking the drug unsafe
- •pregnant or lactating females
- •Exposure to certain anti-cancer or other drugs within a certain period before the start of study drug
研究组 & 干预措施
Dose Level 5
CP-383, single daily oral capsule, 8.0 mg
干预措施: CP-383 (Drug)
Dose Level 3
CP-383, single daily oral capsule, 3.0 mg
干预措施: CP-383 (Drug)
Dose Level 4
CP-383, single daily oral capsule, 5.0 mg
干预措施: CP-383 (Drug)
Dose Level 1
CP-383, single daily oral capsule, 0.8 mg
干预措施: CP-383 (Drug)
Dose Level 2
CP-383, single daily oral capsule, 1.6 mg
干预措施: CP-383 (Drug)
Dose Level 6
CP-383, single daily oral capsule, 12 mg
干预措施: CP-383 (Drug)
Expansion Arm 1
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
干预措施: CP-383 (Drug)
Expansion Arm 2
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
干预措施: CP-383 (Drug)
Expansion Arm 3
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
干预措施: CP-383 (Drug)
Expansion Arm 4
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
干预措施: CP-383 (Drug)
结局指标
主要结局
Part 1: Determine the maximum tolerated dose (MTD)
时间窗: 21 days
Determine the MTD of CP-383 in subjects with advanced solid tumors
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types
时间窗: From enrollment through study completion, an average of 1 year
Objective response rate assessed by the investigator according to RECIST
次要结局
- Part 1: Assess safety and tolerability of CP-383 in participants with advanced solid tumors(From enrollment through study completion, an average of 1 year)
- Part 2: Evaluate safety and tolerability of CP-383 at the recommended Phase 2 dose in selected tumor types(From enrollment through study completion, an average of 1 year)
- Part 1: Determine the pharmacokinetics parameters of CP-383(From enrollment through study completion, an average of 1 year)
- Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types(From enrollment through study completion, an average of 1 year)