Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117479
Recruitment Status : Terminated (The study was terminated early based on the results of the planned interim analysis.)
First Posted : April 21, 2014
Results First Posted : July 11, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Ruxolitinib Drug: Placebo Drug: Capecitabine Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : December 2016


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: Placebo
5 mg tablets to be administered by mouth twice daily (BID)

Drug: Capecitabine
150 and 500 mg tablets to be administered by mouth twice daily (BID)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02117479


Locations
Hide Hide 230 study locations
Layout table for location information
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
United States, Arkansas
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
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
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
United States, Connecticut
New Britain, Connecticut, United States
New Haven, Connecticut, United States
Southington, Connecticut, United States
Trumbull, Connecticut, United States
United States, Delaware
Newark, Delaware, United States
United States, Florida
Boca Raton, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
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
United States, Illinois
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Hinsdale, Illinois, United States
Niles, Illinois, United States
Urbana, Illinois, United States
United States, Indiana
Goshen, Indiana, United States
Indianapolis, Indiana, United States
United States, Kansas
Topeka, Kansas, United States
United States, Kentucky
Ashland, Kentucky, United States
Louisville, Kentucky, United States
United States, Louisiana
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
United States, Maine
Scarborough, Maine, United States
United States, Maryland
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Rockville, Maryland, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
United States, Minnesota
Woodbury, Minnesota, United States
United States, Missouri
Bolivar, Missouri, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
United States, Montana
Kalispell, Montana, United States
United States, Nebraska
Hastings, Nebraska, United States
Omaha, Nebraska, United States
Papillion, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Jersey
East Orange, New Jersey, United States
United States, New Mexico
Farmington, New Mexico, United States
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
United States, North Carolina
Durham, North Carolina, United States
Wake Forest, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
Columbus, Ohio, United States
Middletown, Ohio, United States
Oregon, Ohio, United States
Toledo, Ohio, United States
United States, Oregon
Eugene, Oregon, United States
Portland, Oregon, United States
Springfield, Oregon, United States
Tualatin, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Seneca, South Carolina, United States
Spartanburg, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
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
United States, Utah
Ogden, Utah, United States
Salt Lake City, Utah, United States
United States, Virginia
Blacksburg, Virginia, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Salem, Virginia, United States
Wytheville, Virginia, United States
United States, Washington
Seattle, Washington, United States
Vancouver, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
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
Canada, Ontario
Oshawa, Ontario, Canada
Sault Ste. Marie, Ontario, Canada
Toronto, Ontario, Canada
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
Sponsors and Collaborators
Incyte Corporation
Investigators
Layout table for investigator information
Study Director: Fitzroy Dawkins, M.D. Incyte Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02117479    
Other Study ID Numbers: INCB 18424-362
First Posted: April 21, 2014    Key Record Dates
Results First Posted: July 11, 2017
Last Update Posted: March 26, 2019
Last Verified: March 2019
Keywords provided by Incyte Corporation:
Metastatic pancreatic cancer
Metastatic pancreatic adenocarcinoma that is recurrent
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents