Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

March 14, 2019 updated by: Incyte Corporation

A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor, Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 1 Study)

Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment groups:

  • Treatment A (N = 155): Capecitabine + ruxolitinib
  • Treatment B (N = 155): Capecitabine + placebo

Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered daily for each cycle. Treatment for all participants continued as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued study treatment before study termination were monitored for safety up to 30-35 days from the end of treatment. All participants were followed for survival until study termination or the safety follow-up visit.

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 3

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

  • Australia
      • Australian Capital Territory, Australia
      • New South Wales, Australia
      • South Australia, Australia
      • Victoria, Australia
  • Belgium
      • Aalst, Belgium
      • Brugge, Belgium
      • Bruxelles, Belgium
      • Edegem, Belgium
      • Gent, Belgium
      • Gilly, Belgium
      • Kortrijk, Belgium
      • Leuven, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • Oshawa, Ontario, Canada
      • Sault Ste. Marie, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
      • Laval, Quebec, Canada
      • Montreal, Quebec, Canada
  • Germany
      • Aschaffenburg, Germany
      • Berlin, Germany
      • Bochum, Germany
      • Essen, Germany
      • Frankford, Germany
      • Koeln, Germany
      • Velbert, Germany
  • Italy
      • Aviano, Italy
      • Bari, Italy
      • Bergamo, Italy
      • Brescia, Italy
      • Cremona, Italy
      • Firenze, Italy
      • Genova, Italy
      • Lido di Camaiore, Italy
      • Milano, Italy
      • Napoli, Italy
      • Pisa, Italy
      • Rimini, Italy
      • Roma, Italy
  • Korea, Republic of
      • Hwasun-gun, Korea, Republic of
      • Seongnam-si, Korea, Republic of
      • Seoul, Korea, Republic of
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Hamilton, New Zealand
  • Spain
      • Badajoz, Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Malaga, Spain
      • Seville, Spain
  • Taiwan
      • Taichung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
  • Thailand
      • Patumwan, Thailand
      • Ratchathewi, Thailand
      • Seetatarom, Thailand
  • United Kingdom
      • Aberdeen, United Kingdom
      • Bangor, United Kingdom
      • Birmingham, United Kingdom
      • Boston, United Kingdom
      • Bristol, United Kingdom
      • Cardiff, United Kingdom
      • Glasgow, United Kingdom
      • Guildford, United Kingdom
      • Harlow, United Kingdom
      • Huddersfield, United Kingdom
      • Lancaster, United Kingdom
      • Leeds, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Newcastle upon Tyne, United Kingdom
      • Nottingham, United Kingdom
      • Plymouth, United Kingdom
      • Southampton, United Kingdom
      • Sutton, United Kingdom
      • Welwyn Garden City, United Kingdom
      • Wirral, United Kingdom
  • United States
    • Arizona
      • Avondale, Arizona, United States
      • Chandler, Arizona, United States
      • Gilbert, Arizona, United States
      • Glendale, Arizona, United States
      • Mesa, Arizona, United States
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
      • Surprise, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Jonesboro, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Bakersfield, California, United States
      • Berkeley, California, United States
      • Beverly Hills, California, United States
      • Chula Vista, California, United States
      • Covina, California, United States
      • Downey, California, United States
      • El Cajon, California, United States
      • Fullerton, California, United States
      • Gilroy, California, United States
      • Glendale, California, United States
      • La Mesa, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Lynwood, California, United States
      • Modesto, California, United States
      • Montebello, California, United States
      • Northridge, California, United States
      • Oceanside, California, United States
      • Orange, California, United States
      • Redondo Beach, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • San Luis Obispo, California, United States
      • Santa Ana, California, United States
      • Santa Maria, California, United States
      • Santa Monica, California, United States
      • Torrance, California, United States
      • Whittier, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Boulder, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
      • Grand Junction, Colorado, United States
      • Longmont, Colorado, United States
      • Thornton, Colorado, United States
    • Connecticut
      • New Britain, Connecticut, United States
      • New Haven, Connecticut, United States
      • Southington, Connecticut, United States
      • Trumbull, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
    • Florida
      • Boca Raton, Florida, United States
      • Hollywood, Florida, United States
      • Miami, Florida, United States
      • Pembroke Pines, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Austell, Georgia, United States
      • Carrollton, Georgia, United States
      • Cartersville, Georgia, United States
      • Douglasville, Georgia, United States
      • Marietta, Georgia, United States
      • Newnan, Georgia, United States
      • Rome, Georgia, United States
      • Thomasville, Georgia, United States
    • Illinois
      • Arlington Heights, Illinois, United States
      • Chicago, Illinois, United States
      • Hinsdale, Illinois, United States
      • Niles, Illinois, United States
      • Urbana, Illinois, United States
    • Indiana
      • Goshen, Indiana, United States
      • Indianapolis, Indiana, United States
    • Kansas
      • Topeka, Kansas, United States
    • Kentucky
      • Ashland, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maine
      • Scarborough, Maine, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Baltimore, Maryland, United States
      • Bethesda, Maryland, United States
      • Rockville, Maryland, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Lansing, Michigan, United States
    • Minnesota
      • Woodbury, Minnesota, United States
    • Missouri
      • Bolivar, Missouri, United States
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Montana
      • Kalispell, Montana, United States
    • Nebraska
      • Hastings, Nebraska, United States
      • Omaha, Nebraska, United States
      • Papillion, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • East Orange, New Jersey, United States
    • New Mexico
      • Farmington, New Mexico, United States
    • New York
      • Binghamton, New York, United States
      • Bronx, New York, United States
      • Fresh Meadows, New York, United States
      • Hudson, New York, United States
      • Johnson City, New York, United States
      • New York, New York, United States
      • Nyack, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Wake Forest, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
      • Columbus, Ohio, United States
      • Middletown, Ohio, United States
      • Oregon, Ohio, United States
      • Toledo, Ohio, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
      • Springfield, Oregon, United States
      • Tualatin, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Seneca, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Austin, Texas, United States
      • Beaumont, Texas, United States
      • Bedford, Texas, United States
      • Cedar Park, Texas, United States
      • Dallas, Texas, United States
      • Denton, Texas, United States
      • El Paso, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Plano, Texas, United States
      • Round Rock, Texas, United States
      • San Antonio, Texas, United States
      • Temple, Texas, United States
      • Tyler, Texas, United States
      • Waco, Texas, United States
    • Utah
      • Ogden, Utah, United States
      • Salt Lake City, Utah, United States
    • Virginia
      • Blacksburg, Virginia, United States
      • Richmond, Virginia, United States
      • Roanoke, Virginia, United States
      • Salem, Virginia, United States
      • Wytheville, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Vancouver, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas.
  • Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
  • ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
  • Radiographically measurable or evaluable disease

  • Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

    1. mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
    2. mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L

Exclusion Criteria:

  • Received more than 1 prior regimen for advanced or metastatic disease.
  • Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
  • Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
  • Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
  • Prior treatment with a JAK inhibitor for any indication.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ruxolitinib plus capecitabine
Drug: Ruxolitinib
5 mg tablets to be administered by mouth twice daily (BID)
Other Names:
  • Jakafi ®
  • Jakavi ®
Drug: Capecitabine
150 and 500 mg tablets to be administered by mouth twice daily (BID)
Active Comparator: Placebo plus capecitabine
Drug: Capecitabine
150 and 500 mg tablets to be administered by mouth twice daily (BID)
Drug: Placebo
5 mg tablets to be administered by mouth twice daily (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Randomization until death due to any cause; up to the data cutoff 11FEB2016.
Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
Randomization until death due to any cause; up to the data cutoff 11FEB2016.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Percentage of Participants Achieving Progression Free Survival (PFS)
Time Frame: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Objective Response Rate (ORR)
Time Frame: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Duration of Response
Time Frame: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.
Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.

Collaborators and Investigators

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

Sponsor

Incyte Corporation

Investigators

  • Study Director: Fitzroy Dawkins, M.D., Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 18424-362

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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