Official Title: A Phase 1B/2 Study of the Safety and Tolerability of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Safety and tolerability of combination therapy study treatment itacitinib (INCB039110) plus nab-paclitaxel and gemcitabine as measured by the number of participants with adverse events
研究概览
简要总结
Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.
详细描述
Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that includes identifying the MTD of itacitinib (INCB039110) (within a defined pharmacologic range) in combination with doses of gemcitabine and nab-paclitaxel that have established safety and tolerability in subjects with advanced or metastatic solid tumors.
Study Part 2 and Part 2A: This phase will explore the safety and tolerability of the MTD or PAD of itacitinib (INCB039110) when administered in combination with gemcitabine and nab-paclitaxel in subjects with untreated advanced or metastatic pancreatic cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic adenocarcinoma (Part 2)
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- •Received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neo-adjuvant and/or adjuvant therapy) (Part 1)
- •Received no prior chemotherapy for advanced or metastatic disease (Part 2 and Part 2a)
- •Adequate renal, hepatic, and bone marrow function without frequent blood product or hematopoietic growth factor support (eg use of erythropoietin or transfusions > 2 units packed red blood cells every 3 months)
- •Ability to swallow and retain oral medication
排除标准
- •Any known contraindications to the use of a required comedication (gemcitabine or nab-paclitaxel).
- •Evidence of uncontrolled brain metastases or history of uncontrolled seizures.
- •Ongoing radiation therapy and/or radiation therapy administered within 28 days of enrollment or ongoing radiotherapy-related toxicities.
- •Presence of ≥ Grade 2 neuropathy.
- •Inability to swallow food or any condition of the upper GI tract that precludes administration of oral medications.
- •Recent (≤ 3 months) history of partial or complete bowel obstruction.
- •Unwillingness to be transfused with blood components.
- •Known history of Hepatitis B or C infection or HIV infection
研究组 & 干预措施
itacitinib, gemcitabine, nab-paclitaxel, filgrastim
干预措施: itacitinib (Drug)
itacitinib, gemcitabine, nab-paclitaxel, filgrastim
干预措施: Gemcitabine (Drug)
itacitinib, gemcitabine, nab-paclitaxel, filgrastim
干预措施: nab-paclitaxel (Drug)
itacitinib, gemcitabine, nab-paclitaxel, filgrastim
干预措施: filgrastim (Drug)
结局指标
主要结局
Safety and tolerability of combination therapy study treatment itacitinib (INCB039110) plus nab-paclitaxel and gemcitabine as measured by the number of participants with adverse events
时间窗: Baseline and weekly for Cycle 1 and then Day 1, Week 8 and Week 15 for all subsequent cycles until the End of Treatment visit (approximately 6 months).
Identify the Maximum Tolerated Dose (MTD) or Pharmacologically Active Dose (PAD) within a defined dose range for itacitinib (INCB039110) in the treatment regimens administered
时间窗: Each cohort will be observed for a minimum of 28 days.
次要结局
- Clinical activity as measured by the greatest decrease in tumor burden compared to baseline.(Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months).)
- Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110)(Baseline up to 6 months.)