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2016-03-24
2018-05-22
2022-05
17
NCT02514031
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
INTERVENTIONAL
ARQ-761 Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Pancreatic Cancer
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-06-17 | N/A | 2022-05-31 |
2015-07-30 | N/A | 2022-06-03 |
2015-08-03 | N/A | 2022-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 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 gem | DRUG: ARQ-761
DRUG: Gemcitabine
DRUG: nab-paclitaxel
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | Determine the maximum tolerated dose (MTD) of ARQ761 when given in combination with gemcitabine and nab-paclitaxel (GEM-Nab-Pac). | 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. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Safety will be assessed by quantifying toxicities using the NCI's CTCAE v4.0 toxicity criteria | 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 | CT Chest/Abdomen/Pelvis to determine clinical activity as defined by overall response rate (ORR). | Imaging will be done every 2-3 months until you are off treatment (Up to 8 months). |
| Progression Free Survival | CT Chest/Abdomen/Pelvis to determine clinical activity as defined by 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 | CT Chest/Abdomen/Pelvis to determine clinical activity as defined by 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 | The pharmacokinetic profile of ARQ761 will be determined by measurement of blood levels at predetermined time points. | During Cycle 1 Day 1 and Cycle 1 Day 15 |
| Tolerability | Tolerability 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. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
