A Phase I/Ib, Single-Arm, Open-Label, Multi-Center Trial Using ARQ-761 (Beta-Lapachone) Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Metastatic, Unresectable, Or Recurrent Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This is a study of ARQ-761 (beta-lapachone) with gemcitabine/nab-paclitaxel chemotherapy in subjects with advanced (metastatic, unresectable, or recurrent) pancreatic cancer that has not been treated with gemcitabine.
详细描述
Screening:
- Demographic information (age, gender, race, ethnic origin).
- Physical exam and review of your past and present medical history including any surgeries a and/or infections;
- Vital signs (temperature, pulse, respirations, blood pressure); height, weight;
- Concurrent medications (medications whether prescribed or over-the counter that you have taken or are currently taking);
- Performance Status (how well you are able to perform daily activities)
- Review of any side effects that you may have experienced or may be experiencing before receiving the study drug and medications
- Blood will be collected for routine lab tests
- Urinalysis
- Pregnancy Test (if you are a woman of child-bearing potential)
- Radiologic evaluation (review of any CT scans you may have had)
- Tumor measurements:
- A CT scan (chest/abdomen/pelvis) is a special test that produces an image of your body using a. small amount of radiation. The image shows the body tissues and structures in three dimensions (3-D).
- Electrocardiogram (EKG), a tracing of the electrical activity of the heart;
- Oxygen saturation (measures how much oxygen the blood is carrying)
- Biopsy for correlative studies - if archived tumor specimen cannot be obtained, you will need to undergo a fresh biopsy
- Completion of a Quality of life questionnaire
This visit may last approximately 1-2 hours. Visits that included radiologic evaluation may last longer, approximately 2-3 hours.
The treatment consists of:
- A 2 week lead-in monotherapy of ARQ-761 - they will receive the current dose of ARQ761 alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Subjects must have a histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic, unresectable, or recurrent.
- •Has received at most 1 line of prior non-gemcitabine chemotherapy for:
- •metastatic/unresectable disease.
- •Prior adjuvant gemcitabine, if completed more than 12 months prior to enrollment is not considered as prior line of therapy.
- •Radiosensitizing chemotherapy will not be considered a prior line of therapy.
- •Prior and concurrent therapy
- •Measurable disease is required per RECIST criteria 1.
- •Age ≥18 years.
- •ECOG performance status 0 or 1
- •Anticipated life expectancy ≥ three months.
- •Central venous access
- •Availability of unstained slides or paraffin block tissue from archived tumor specimen. If not available the subject will undergo a fresh biopsy.
- •Specific pretreatment clinical laboratory parameters that are required within 14 days prior to registration.
- •Subjects must be recovered from any toxicity related to prior anti-neoplastic therapy (to grade <1).
- •Women of child-bearing potential and men must agree to use adequate contraception hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
排除标准
- •Receiving any other investigational agents.
- •Subjects with known untreated brain metastases.
- •Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD
- •Uncontrolled intercurrent illness
- •Any significant medical condition, laboratory abnormality, or psychiatric illness.
- •Any condition including the presence of laboratory abnormalities.
- •Any condition that confounds the ability to interpret data from the study.
- •Unwillingness or inability to comply with study procedures.
研究组 & 干预措施
ARQ-761
A 2 week lead-in monotherapy of ARQ-761 (The amount of ARQ-761 that will be given to the participant will depend on the time at which the participant was enrolled in the study
Afterwards the 28-day cycle of combination treatment of ARQ-761 along with gemcitabine (1000 mg/m2) + nab-paclitaxel (125 mg/m2) will begin.
干预措施: ARQ-761 (Drug)
ARQ-761
A 2 week lead-in monotherapy of ARQ-761 (The amount of ARQ-761 that will be given to the participant will depend on the time at which the participant was enrolled in the study
Afterwards the 28-day cycle of combination treatment of ARQ-761 along with gemcitabine (1000 mg/m2) + nab-paclitaxel (125 mg/m2) will begin.
干预措施: Gemcitabine (Drug)
ARQ-761
A 2 week lead-in monotherapy of ARQ-761 (The amount of ARQ-761 that will be given to the participant will depend on the time at which the participant was enrolled in the study
Afterwards the 28-day cycle of combination treatment of ARQ-761 along with gemcitabine (1000 mg/m2) + nab-paclitaxel (125 mg/m2) will begin.
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Day 8, Day 1 and Day 15 every 28 days for 168 days or until disease progression, Off Treatment (Up to 8 months) , and 4 weeks after treatment.
Determine the maximum tolerated dose (MTD) of ARQ761 when given in combination with gemcitabine and nab-paclitaxel (GEM-Nab-Pac).
次要结局
- Safety will be assessed by quantifying toxicities using the NCI's CTCAE v4.0 toxicity criteria(Day 8 , Day 1 and Day 15 every 28 days for 168 days or until disease progression, Off Treatment (Up to 8 months) , and 4 weeks after treatment.)
- Overall Response Rate(Imaging will be done every 2-3 months until you are off treatment (Up to 8 months).)
- Progression Free Survival(Imaging will be done every 2nd cycle starting with week 10 (cycle 2) until you are off treatment (Up to 8 months).)
- Time To Progression(Imaging will be done every 2nd cycle starting with week 10 (cycle 2) until you are off treatment (Up to 8 months).)
- Pharmacokinetic Profile(During Cycle 1 Day 1 and Cycle 1 Day 15)
- Tolerability(Day 8, Day 1 and Day 15 every 28 days for 168 days or until disease progression, Off Treatment (Up to 8 months) , and 4 weeks after treatment.)
研究者
Muhammad Beg
Associate Professor of Medicine
University of Texas Southwestern Medical Center