NCT02514031

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at P25-P50 for phase_1 pancreatic-cancer

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

March 24, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2018

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

June 3, 2022

Status Verified

May 1, 2022

Enrollment Period

2.2 years

First QC Date

June 17, 2015

Last Update Submit

May 31, 2022

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

    Imaging will be done every 2-3 months until you are off treatment (Up to 8 months).

  • 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

    Imaging will be done every 2nd cycle starting with week 10 (cycle 2) until you are off treatment (Up to 8 months).

  • Pharmacokinetic Profile

    During Cycle 1 Day 1 and Cycle 1 Day 15

  • +1 more secondary outcomes

Study Arms (1)

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.

Drug: ARQ-761Drug: GemcitabineDrug: nab-paclitaxel

Interventions

ARQ-761DRUG

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

Also known as: Beta-Lapachone
ARQ-761
GemcitabineDRUG

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.

Also known as: Gemzar
ARQ-761
nab-paclitaxelDRUG

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.

Also known as: Abraxane
ARQ-761

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \. 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.
  • \. Specific pretreatment clinical laboratory parameters that are required within 14 days prior to registration.
  • \. Subjects must be recovered from any toxicity related to prior anti-neoplastic therapy (to grade \<1).
  • \. 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-8852, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

beta-lapachoneGemcitabine130-nm albumin-bound paclitaxelAlbumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Muhammad Beg, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 17, 2015

First Posted

August 3, 2015

Study Start

March 24, 2016

Primary Completion

May 22, 2018

Study Completion

May 1, 2022

Last Updated

June 3, 2022

Record last verified: 2022-05

Locations

US(2)