A Study of Ruxolitinib in Pancreatic Cancer Patients

January 15, 2018 updated by: Incyte Corporation

A Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 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 2 Study)

This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of 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 270 participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were to be randomized (1:1) to one of the following treatment groups:

  • Treatment A (N = 135): Capecitabine + ruxolitinib
  • Treatment B (N = 135): 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 during the entire cycle. Treatment for all participants was to continue as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued treatment continued to be followed for subsequent anticancer treatments and survival.

Study Type

Interventional

Enrollment (Actual)

86

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

  • Austria
      • Graz, Austria
      • Linz, Austria
      • Salzburg, Austria
      • Vienna, Austria
      • Wein, Austria
  • Chile
      • Santiago, Chile
      • Vitacura, Chile
  • Colombia
      • Bogota, Colombia
      • Medellin, Colombia
  • Denmark
      • Naestved, Denmark
      • Odense C, Denmark
  • France
      • Bordeaux, France
      • Brest Cedex, France
      • Dijon, France
      • Lyon, France
      • Nancy, France
  • Ireland
      • Cork, Ireland
      • Dubin, Ireland
      • Galway, Ireland
  • Israel
      • Beer Sheva, Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Petach Tikva, Israel
      • Ramat Gan, Israel
      • Tel Aviv, Israel
      • Tel Hashomer, Israel
  • Mexico
      • Monterrey, Mexico
      • Oaxaca, Mexico
      • Toluca, Mexico
  • Netherlands
      • Amsterdam, Netherlands
      • Maastricht, Netherlands
      • Nijmegen, Netherlands
  • Portugal
      • Braga, Portugal
      • Lisboa, Portugal
      • Porto, Portugal
  • Puerto Rico
      • San Juan, Puerto Rico
  • Sweden
      • Linköping, Sweden
      • Uppsala, Sweden
  • Switzerland
      • Bellinzona, Switzerland
      • Geneve, Switzerland
  • United States
    • Alabama
      • Huntsville, Alabama, United States
    • Arkansas
      • Fayetteville, Arkansas, United States
    • California
      • Beverly Hills, California, United States
      • La Jolla, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Denver, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Fort Myers, Florida, United States
      • Saint Petersburg, Florida, United States
    • Georgia
      • Athens, Georgia, United States
      • Atlanta, Georgia, United States
      • Macon, Georgia, United States
      • Thomasville, Georgia, United States
    • Illinois
      • Harvey, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Farmington Hills, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Lansing, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Saint Louis Park, Minnesota, United States
    • Missouri
      • Bolivar, Missouri, United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
      • Cherry Hill, New Jersey, United States
      • Voorhees, New Jersey, United States
    • New York
      • Commack, New York, United States
      • Fresh Meadows, New York, United States
      • Harrison, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
      • Rockville Centre, New York, United States
      • Sleepy Hollow, New York, United States
    • Ohio
      • Canton, Ohio, United States
      • Cincinnati, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Hershey, Pennsylvania, United States
      • Langhorne, Pennsylvania, United States
    • South Carolina
      • Greenville, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Lubbock, Texas, United States
      • San Antonio, Texas, United States
      • Temple, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Falls Church, Virginia, United States
      • Newport News, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Green Bay, 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

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

    • Criteria:

      1. mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ≥ 35 g/L
      2. mGPS of 2: CRP > 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).
  • Current or previous other malignancy within 2 years of study entry without sponsor approval
  • Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), 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 mg or 500 mg tablets to be administered by mouth twice daily (BID)
Active Comparator: Placebo plus capecitabine
Drug: Capecitabine
150 mg or 500 mg tablets to be administered by mouth twice daily (BID)
Drug: Placebo
5 mg matching placebo 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 6-months or to the data cutoff 11FEB2016.
Overall survival is reported here based on the number of deaths from randomization until the data cut-off.
Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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 as 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 Response Evaluation Criteria in Solid Tumours RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by RECIST at any post baseline visit. Per 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. Per 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.

Collaborators and Investigators

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

Sponsor

Incyte Corporation

Investigators

  • Study Director: Fitzroy Dawkins, MD, 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)

June 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

January 15, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 18424-363

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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