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Trial record 2 of 2 for:    ARQ 761

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

This study is currently recruiting participants.
Verified May 2016 by University of Texas Southwestern Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02514031
First Posted: August 3, 2015
Last Update Posted: June 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  Purpose
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.

Condition Intervention Phase
Pancreatic Cancer Drug: ARQ-761 Drug: Gemcitabine Drug: nab-paclitaxel Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.

  • 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).

  • 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 .

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 20
Study Start Date: October 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Abraxane

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514031


Contacts
Contact: Joyce Bolluyt 214-648-7007 joyce.bolluyt@UTSouthwestern.edu
Contact: Muhammad Beg, MD 214-648-4180 muhammad.beg@UTSouthwestern.edu

Locations
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Not yet recruiting
Baltimore, Maryland, United States, 21231
Contact: Stefanie Porter    410-614-4626    Sporter@jhmi.edu   
Contact: Dan Laheru, MD    410-955-8974    Laherda@jhmi.edu   
Principal Investigator: Dan Laheru, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8852
Contact: Joyce Bolluyt    214-648-7007    joyce.bolluyt@UTSouthwestern.edu   
Contact: Muhammad Beg, MD    214-648-4180    muhammad.beg@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Muhammad Beg, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02514031     History of Changes
Other Study ID Numbers: STU 052015-024
First Submitted: June 17, 2015
First Posted: August 3, 2015
Last Update Posted: June 1, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Beta-lapachone
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents