ARQ-761 Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Pancreatic Cancer

Overview

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.

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 o The amount of ARQ-761 that will be given to you will depend on the time at which you are 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 Lead-in 2 weeks before the combination therapy begins: Monotherapy of ARQ-761 Day 1: * Vital signs * Review of medical history * Physical exam * Review of any medications they are taking or have taken * Review of any adverse events they may have experienced * Performance status evaluation (questions about their activity level) * Quality of life assessment questionnaire * Blood will be drawn for routine laboratory tests * Urinalysis * Oxygen saturation measurement using a finger light sensor * EKG * ARQ761 Administration via intravenous (IV) for approximately 120 minutes Clinic Visit: 3 - 3 ½ Hours Combination Therapy: Cycle 1 Day 1 * Vital signs * Review of medical history and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Quality of life assessment questionnaire * Blood work * Blood for correlative studies * Urinalysis * EKG * Oxygen saturation measurement using a finger light sensor Combination Treatment regimen: * Nab-Paclitaxel administered via intravenous (IV) over 30 minutes then; * Gemcitabine administered via intravenous (IV) over 30 minutes After waiting for 60 minutes (1 hour) then: * ARQ 761 administered via intravenous (IV) over 120 minutes (2 hours) * Biopsy of their tumor * PKs (pharmacokinetics) (consist of drawing of approximately ½ teaspoon of blood to determine what their body does to the study drug) will be collected at: * Pre-Infusion of ARQ-761 * 30 minutes after beginning of infusion * 1, 2, and 4 hour post-infusion of ARQ-761 * PDs (pharmacodynamics) (consist of drawing of approximately ½ teaspoon of blood to examine the response of protein biomarkers in patients treated with ARQ-761during the clinical trial) will be collected: * Pre-infusion of ARQ-761 * 3 hour post-infusion of ARQ-761 Clinic Visit: 8 Hours Cycle 1 Day 8 * Vital signs * History and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Blood work * Nab-Paclitaxel administered via intravenous (IV) over 30 minutes then; * Gemcitabine administered via intravenous (IV) over 30 minutes Clinic Visit: 2 hours Cycle 1 Day 15 * Vital signs * History and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Blood work * Blood for correlative studies * Urinalysis * EKG * Oxygen saturation measurement using a finger light sensor Treatment regimen: * Nab-Paclitaxel administered via intravenous (IV) over 30 minutes then; * Gemcitabine administered via intravenous (IV) over 30 minutes After waiting for 60 minutes (1 hour) then: * ARQ 761 administered via intravenous (IV) over 120 minutes (2 hours) * PKs (pharmacokinetics) (consist of drawing of approximately ½ teaspoon of blood to determine what their body does to the study drug) will be collected at: * Pre-Infusion of ARQ-761 * 30 minutes after beginning of infusion * 1, 2, and 4 hour post-infusion of ARQ-761 * PDs (pharmacodynamics) (consist of drawing of approximately ½ teaspoon of blood to examine the response of protein biomarkers in patients treated with ARQ-761during the clinical trial) will be collected: * Pre-infusion of ARQ-761 * 3 hour post-infusion of ARQ-761 Clinic Visit: 8 hours Cycle 2 Day 1 * Vital signs * History and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Oxygen saturation measurement using a finger light sensor * Blood work * Urinalysis * Oxygen saturation measurement using a finger light sensor * Quality of life assessment Combination treatment regimen same as for Cycle 1 Day 1 Clinic Visit: 5 - 6 hours Cycle 2 Day 8 * Vital signs * A nurse will ask them general screening questions * Blood work * Nab-Paclitaxel administered via intravenous (IV) over 30 minutes then; * Gemcitabine administered via intravenous (IV) over 30 minutes Clinic Visit: 2-3 hours Cycle 2 Day 15 * Vital signs * History and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Blood work * Urinalysis * Oxygen saturation measurement using a finger light sensor Combination treatment regimen same as for Cycle 1 Day 1 Clinic Visit: 5 - 6 hours Cycle 2 Day 27 • CT scan of their chest/abdomen/pelvis Clinic Visit: 1 - 2 hours Cycle 3 and all subsequent odd cycles Day 1 * Vital signs * History and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Quality of life assessment questionnaire * Blood work * Urinalysis * Oxygen saturation measurement using a finger light sensor Combination treatment regimen same as for Cycle 1 Day 1 Clinic Visit: 5 - 6 hours Cycle 3 and all subsequent odd cycles Day 8 * Vital signs * A nurse will ask them general screening questions * Blood work * Nab-Paclitaxel administered via intravenous (IV) over 30 minutes then; * Gemcitabine administered via intravenous (IV) over 30 minutes Clinic Visit: 2-3 hours Cycle 3 and all subsequent odd cycles Day 15 * Vital signs * History and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Blood work * Urinalysis * Oxygen saturation measurement using a finger light sensor * Combination treatment regimen same as for Cycle 1 Day 1 Clinic Visit: 6 hours Cycle 4 and all subsequent even cycles Day 1 * Vital signs * History and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Quality of life assessment questionnaire * Blood work * Urinalysis * Oxygen saturation measurement using a finger light sensor Combination treatment regimen same as for Cycle 1 Day 1 Clinic Visit: 6 hours Cycle 4 and all subsequent even cycles Day 8 * Vital signs * A nurse will ask them general screening questions * Blood work * Nab-Paclitaxel administered via intravenous (IV) over 30 minutes then; * Gemcitabine administered via intravenous (IV) over 30 minutes Clinic Visit: 2-3 hours Cycle 4 and all subsequent even cycles Day 15 * Vital signs * History and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Blood work * Urinalysis * Oxygen saturation measurement using a finger light sensor Combination treatment regimen same as for Cycle 1 Day 1 Clinic Visit: 6 hours Cycle 4 and all subsequent even cycles Day 27 • CT scan of their chest/abdomen/pelvis Clinic Visit: 1 - 2 hours Off-Treatment Visit/End of Study Visit * Vital signs * History and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Quality of life assessment questionnaire * Blood work * Blood for correlative studies * Urinalysis * Oxygen saturation measurement using a finger light sensor Clinic Visit: 1 - 2 hours Follow-up Procedures They will be seen once at 4 weeks after completion of (or early withdrawal from) study treatment. This visit will be repeated every 4 weeks until resolution of any side effects. The following will be done at this visit: * Vital signs * History and physical exam * Performance status evaluation (questions about their activity level) * Toxicity evaluation (questions about their side effects) * Blood work

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