Pancreatic CancerPhase 1NCT02514031
ARQ-761 Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Pancreatic Cancer
A Phase 1 study testing ARQ-761, Gemcitabine and nab-paclitaxel in people with Pancreatic Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- ARQ-761, Gemcitabine and nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Mar 2016to May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 therapy4. Measurable disease is required per RECIST criteria 1.1.
Show all 10Show fewer
- 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.
Who cannot join
- Receiving any other investigational agents.
- Subjects with known untreated brain metastases.
- Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD
- Uncontrolled intercurrent illness
- Pregnancy
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
UT Southwestern Medical Center
Dallas, Texas, 75390-8852
About this study
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
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.
Read the 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
- 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
- Conditions
- Pancreatic Cancer
- Being tested
- ARQ-761, Gemcitabine, nab-paclitaxel
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ-761Drug
Also called Beta-Lapachone
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
GemcitabineDrug
Also called Gemzar
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.
nab-paclitaxelDrug
Also called Abraxane
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.
| Study group | Role | What they receive |
|---|---|---|
| ARQ-761 | Experimental | 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. Receives: Drug: ARQ-761; Drug: Gemcitabine; Drug: nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Determine the maximum tolerated dose (MTD) of ARQ761 when given in combination with gemcitabine and nab-paclitaxel (GEM-Nab-Pac).
Measured: 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 outcomes (6)
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.
Measured: 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).
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study start24 Mar 2016
- Primary completion22 May 2018
- Study completionMay 2022
Why it stopped: The study placed on temporarily hold to enrollment due to quality testing necessary for the study drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Beg, University of Texas Southwestern Medical Center
- Investigators
- Muhammad Beg, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514031
- Sponsor's protocol ID
- STU 052015-024
- Status last verified
- May 2022
- First submitted
- 17 Jun 2015
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02514031
- Acronym / sponsor ID
- STU 052015-024
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study placed on temporarily hold to enrollment due to quality testing necessary for the study drug.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARQ-761 | Experimental | Drug: ARQ-761, Drug: Gemcitabine, Drug: nab-paclitaxelA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (7 listed)
- Receiving any other investigational agents.
- Subjects with known untreated brain metastases.
- Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD
- Uncontrolled intercurrent illness
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARQ-761Also: Beta-LapachoneDose 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 | Drug | ARQ-761 |
| GemcitabineAlso: GemzarTherapy 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. | Drug | ARQ-761 |
| nab-paclitaxelAlso: AbraxaneTherapy 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. | Drug | ARQ-761 |
Primary outcome
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).
6 secondary outcomes
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.
Overall Response Rate
Time frame: 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).
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).
Pharmacokinetic Profile
Time frame: 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.
Results and safety
The study was stopped early (reason given: The study placed on temporarily hold to enrollment due to quality testing necessary for the study drug.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Beg, MD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARQ-761, Gemcitabine and nab-paclitaxel in people with Pancreatic Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study placed on temporarily hold to enrollment due to quality testing necessary for the study drug.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.