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

Pancreatic Cancer Clinical Trial

Official title: 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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT02514031
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Terminated
• Phase: Phase 1
• Start date: March 24, 2016
• Completion date: May 2022