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

May 31, 2022 updated by: Muhammad Beg, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390-8852
        • UT Southwestern Medical Center

Participation Criteria

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects must have a histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic, unresectable, or recurrent.

  2. 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.
  3. Prior and concurrent therapy4. Measurable disease is required per RECIST criteria 1.1.

5. Age ≥18 years. 6. ECOG performance status 0 or 1 7. Anticipated life expectancy ≥ three months. 8. Central venous access 9. Availability of unstained slides or paraffin block tissue from archived tumor specimen. If not available the subject will undergo a fresh biopsy.

10. Specific pretreatment clinical laboratory parameters that are required within 14 days prior to registration.

11. Subjects must be recovered from any toxicity related to prior anti-neoplastic therapy (to grade <1).

12. 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.

Exclusion Criteria:

  1. Receiving any other investigational agents.
  2. Subjects with known untreated brain metastases.
  3. Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD
  4. Uncontrolled intercurrent illness
  5. Pregnancy
  6. Any significant medical condition, laboratory abnormality, or psychiatric illness. 7. Any condition including the presence of laboratory abnormalities.

8. Any condition that confounds the ability to interpret data from the study. 9. Unwillingness or inability to comply with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 gemcitabine (1000 mg/m2) + nab-paclitaxel (125 mg/m2) will begin.
Drug: ARQ-761

Dose Level 1:

ARQ761 195 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1, 8, 15 Nab paclitaxel 125 mg/m2 D1, 8, 15

Dose Level 2:

ARQ761 290 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1,8,15

Dose Level 3:

ARQ761 390 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1,8,15 Nab-paclitaxel 125 mg/m2 D1,8,15

Expansion Dose Level:

ARQ761 390 IV mg or as tolerated D1, 15 Gemcitabine 1000 mg/m2 D1,8,15 Nab-Paclitaxel 125 mg/m2 D1,8,15

Other Names:
  • Beta-Lapachone
Drug: Gemcitabine

Therapy after lead in Phase:

You will receive Gemcitabine (1000mg/m2) administered intravenously on Days 1,8, 15-every 28 days. All cycles are 28 days in duration and there are no rest periods between cycles. You may continue treatment after cycle 6 until disease progression.

Other Names:
  • Gemzar
Drug: nab-paclitaxel

Therapy after lead in phase:

You will receive nab-paclitaxel (125 mg/m2) administered intravenously on Days 1,8, 15-every 28 days. All cycles are 28 days in duration and there are no rest periods between cycles. You may continue treatment after cycle 6 until disease progression.

Other Names:
  • Abraxane

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose
Time Frame: 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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety will be assessed by quantifying toxicities using the NCI's CTCAE v4.0 toxicity criteria
Time Frame: 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.
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
Time Frame: Imaging will be done every 2-3 months until you are off treatment (Up to 8 months).
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
Time Frame: Imaging will be done every 2nd cycle starting with week 10 (cycle 2) until you are off treatment (Up to 8 months).
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
Time Frame: Imaging will be done every 2nd cycle starting with week 10 (cycle 2) until you are off treatment (Up to 8 months).
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
Time Frame: During Cycle 1 Day 1 and Cycle 1 Day 15
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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muhammad Beg, MD, University of Texas Southwestern Medical Center

Study record dates

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU 052015-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on ARQ-761

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings