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Pancreatic CancerPhase 3NCT02117479

Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

A Phase 3 study testing Ruxolitinib and Capecitabine in people with Pancreatic Cancer, run by Incyte Corporation at 230 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer. 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?
Ruxolitinib and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
321 participants
Where
230 sitesin 12 countries
Study dates
Mar 2014to Dec 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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
Show all 9Show fewer
  • Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
  • mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
  • mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L

Who cannot join

  • 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.

Trial locations and contacts

230 sites in 12 countries.

230 sites in 12 countries

United States153 sites

  • Study site

    Anaheim, California

  • Study site

    Ann Arbor, Michigan

  • Study site

    Annapolis, Maryland

  • Study site

    Arlington, Texas

  • Study site

    Arlington Heights, Illinois

  • Study site

    Ashland, Kentucky

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Austell, Georgia

  • Study site

    Austin, Texas

  • Study site

    Avondale, Arizona

  • Study site

    Bakersfield, California

  • Study site

    Baltimore, Maryland

  • Study site

    Beaumont, Texas

  • Study site

    Bedford, Texas

  • Study site

    Berkeley, California

  • Study site

    Bethesda, Maryland

  • Study site

    Beverly Hills, California

  • Study site

    Binghamton, New York

  • Study site

    Blacksburg, Virginia

  • Study site

    Boca Raton, Florida

  • Study site

    Bolivar, Missouri

  • Study site

    Boulder, Colorado

  • Study site

    Canton, Ohio

  • Study site

    Carrollton, Georgia

  • Study site

    Cartersville, Georgia

  • Study site

    Cedar Park, Texas

  • Study site

    Chandler, Arizona

  • Study site

    Charleston, South Carolina

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Ohio

  • Study site

    Covina, California

  • Study site

    Dallas, Texas

  • Study site

    Denton, Texas

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Douglasville, Georgia

  • Study site

    Downey, California

  • Study site

    Durham, North Carolina

  • Study site

    East Orange, New Jersey

  • Study site

    El Cajon, California

  • Study site

    El Paso, Texas

  • Study site

    Eugene, Oregon

  • Study site

    Farmington, New Mexico

  • Study site

    Fort Worth, Texas

  • Study site

    Fresh Meadows, New York

  • Study site

    Fullerton, California

  • Study site

    Gilbert, Arizona

  • Study site

    Gilroy, California

  • Study site

    Glendale, Arizona

  • Study site

    Glendale, California

  • Study site

    Goshen, Indiana

  • Study site

    Grand Junction, Colorado

  • Study site

    Hastings, Nebraska

  • Study site

    Hinsdale, Illinois

  • Study site

    Hollywood, Florida

  • Study site

    Hot Springs, Arkansas

  • Study site

    Houston, Texas

  • Study site

    Hudson, New York

  • Study site

    Indianapolis, Indiana

  • Study site

    Johnson City, New York

  • Study site

    Jonesboro, Arkansas

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kalispell, Montana

  • Study site

    Kansas City, Missouri

  • Study site

    Knoxville, Tennessee

  • Study site

    La Mesa, California

  • Study site

    Lansing, Michigan

  • Study site

    Las Vegas, Nevada

  • Study site

    Lebanon, New Hampshire

  • Study site

    Long Beach, California

  • Study site

    Longmont, Colorado

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lynwood, California

  • Study site

    Madison, Wisconsin

  • Study site

    Marietta, Georgia

  • Study site

    Memphis, Tennessee

  • Study site

    Mesa, Arizona

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Middletown, Ohio

  • Study site

    Modesto, California

  • Study site

    Montebello, California

  • Study site

    Nashville, Tennessee

  • Study site

    New Britain, Connecticut

  • Study site

    New Haven, Connecticut

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Newnan, Georgia

  • Study site

    Niles, Illinois

  • Study site

    Northridge, California

  • Study site

    Nyack, New York

  • Study site

    Oceanside, California

  • Study site

    Ogden, Utah

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Oregon, Ohio

  • Study site

    Papillion, Nebraska

  • Study site

    Pembroke Pines, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Plano, Texas

  • Study site

    Portland, Oregon

  • Study site

    Redondo Beach, California

  • Study site

    Richmond, Virginia

  • Study site

    Roanoke, Virginia

  • Study site

    Rochester, New York

  • Study site

    Rockville, Maryland

  • Study site

    Rome, Georgia

  • Study site

    Round Rock, Texas

  • Study site

    Salem, Virginia

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    San Luis Obispo, California

  • Study site

    Santa Ana, California

  • Study site

    Santa Maria, California

  • Study site

    Santa Monica, California

  • Study site

    Scarborough, Maine

  • Study site

    Scottsdale, Arizona

  • Study site

    Seattle, Washington

  • Study site

    Seneca, South Carolina

  • Study site

    Southington, Connecticut

  • Study site

    Spartanburg, South Carolina

  • Study site

    Springfield, Oregon

  • Study site

    St Louis, Missouri

  • Study site

    Surprise, Arizona

  • Study site

    Temple, Texas

  • Study site

    The Bronx, New York

  • Study site

    Thomasville, Georgia

  • Study site

    Thornton, Colorado

  • Study site

    Toledo, Ohio

  • Study site

    Topeka, Kansas

  • Study site

    Torrance, California

  • Study site

    Trumbull, Connecticut

  • Study site

    Tualatin, Oregon

  • Study site

    Tucson, Arizona

  • Study site

    Tyler, Texas

  • Study site

    Urbana, Illinois

  • Study site

    Vancouver, Washington

  • Study site

    Waco, Texas

  • Study site

    Wake Forest, North Carolina

  • Study site

    Whittier, California

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Woodbury, Minnesota

  • Study site

    Worcester, Massachusetts

  • Study site

    Wytheville, Virginia

Other trials in United States

United Kingdom21 sites

  • Study site

    Aberdeen

  • Study site

    Bangor

  • Study site

    Birmingham

  • Study site

    Boston

  • Study site

    Bristol

  • Study site

    Cardiff

  • Study site

    Glasgow

  • Study site

    Guildford

  • Study site

    Harlow

  • Study site

    Huddersfield

  • Study site

    Lancaster

  • Study site

    Leeds

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Metropolitan Borough of Wirral

  • Study site

    Newcastle upon Tyne

  • Study site

    Nottingham

  • Study site

    Plymouth

  • Study site

    Southampton

  • Study site

    Sutton

  • Study site

    Welwyn Garden City

Other trials in United Kingdom

Italy13 sites

  • Study site

    Aviano

  • Study site

    Bari

  • Study site

    Bergamo

  • Study site

    Brescia

  • Study site

    Cremona

  • Study site

    Florence

  • Study site

    Genova

  • Study site

    Lido di Camaiore

  • Study site

    Milan

  • Study site

    Naples

  • Study site

    Pisa

  • Study site

    Rimini

  • Study site

    Roma

Other trials in Italy

Belgium8 sites

  • Study site

    Aalst

  • Study site

    Bruges

  • Study site

    Brussels

  • Study site

    Edegem

  • Study site

    Ghent

  • Study site

    Gilly

  • Study site

    Kortrijk

  • Study site

    Leuven

Other trials in Belgium

Canada7 sites

  • Study site

    Calgary, Alberta

  • Study site

    Greenfield Park, Quebec

  • Study site

    Laval, Quebec

  • Study site

    Montreal, Quebec

  • Study site

    Oshawa, Ontario

  • Study site

    Sault Ste. Marie, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

Germany7 sites

  • Study site

    Aschaffenburg

  • Study site

    Berlin

  • Study site

    Bochum

  • Study site

    Cologne

  • Study site

    Essen

  • Study site

    Frankford

  • Study site

    Velbert

Other trials in Germany

Spain5 sites

  • Study site

    Badajoz

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Seville

Other trials in Spain

Australia4 sites

  • Study site

    Australian Capital Territory

  • Study site

    New South Wales

  • Study site

    South Australia

  • Study site

    Victoria

Other trials in Australia

New Zealand3 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Hamilton

Other trials in New Zealand

South Korea3 sites

  • Study site

    Hwasun-gun

  • Study site

    Seongnam-si

  • Study site

    Seoul

Other trials in South Korea

Taiwan3 sites

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

Other trials in Taiwan

Thailand3 sites

  • Study site

    Patumwan

  • Study site

    Ratchathewi

  • Study site

    Seetatarom

Other trials in Thailand

About this study

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)

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

Read the 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.

Being tested
Ruxolitinib, Placebo, Capecitabine
Keywords
Metastatic pancreatic cancer, Metastatic pancreatic adenocarcinoma that is recurrent
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RuxolitinibDrug

    Also called Jakafi ®, Jakavi ®

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

  • PlaceboDrug

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

  • CapecitabineDrug

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

Study groups in NCT02117479
Study groupRoleWhat they receive
Ruxolitinib plus capecitabineExperimentalNot described
Receives: Drug: Ruxolitinib; Drug: Capecitabine
Placebo plus capecitabineActive comparatorNot described
Receives: Drug: Placebo; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.

    Measured: Randomization until death due to any cause; up to the data cutoff 11FEB2016.

Secondary outcomes (5)

  1. Progression-free Survival (PFS)

    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.

    Measured: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.

  2. Percentage of Participants Achieving Progression Free Survival (PFS)

    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.

    Measured: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.

  3. Objective Response Rate (ORR)

    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.

    Measured: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.

  4. Duration of Response

    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.

    Measured: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.

  5. Participants With Treatment-Emergent Adverse Events (TEAEs)

    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).

    Measured: Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionFeb 2016
  4. Study completionDec 2016

Why it stopped: The study was terminated early based on the results of the planned interim analysis.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02117479
Sponsor's protocol ID
INCB 18424-362
Status last verified
Mar 2019
First submitted
16 Apr 2014
Last updated
26 Mar 2019
Data monitoring committee
Yes

Publications

  • Hurwitz H, Van Cutsem E, Bendell J, Hidalgo M, Li CP, Salvo MG, Macarulla T, Sahai V, Sama A, Greeno E, Yu KH, Verslype C, Dawkins F, Walker C, Clark J, O'Reilly EM. Ruxolitinib + capecitabine in advanced/metastatic pancreatic cancer after disease progression/intolerance to first-line therapy: JANUS 1 and 2 randomized phase III studies. Invest New Drugs. 2018 Aug;36(4):683-695. doi: 10.1007/s10637-018-0580-2. Epub 2018 Mar 6.

    PubMed 29508247

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ruxolitinib and Capecitabine in people with Pancreatic Cancer, run by Incyte Corporation at 230 sites in 12 countries.

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 9 inclusion and 5 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 230 sites in United States, United Kingdom, Italy, Belgium, Canada and 7 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (OS) (time frame: Randomization until death due to any cause; up to the data cutoff 11FEB2016.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02117479, which also lists 1 linked publication.

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 26 Mar 2019.

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