This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback
Trial record 1 of 1 for:    janus1
Previous Study | Return to List | Next Study

Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Incyte Corporation Identifier:
First received: April 16, 2014
Last updated: October 3, 2016
Last verified: October 2016
To determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

Condition Intervention Phase
Metastatic Pancreatic Adenocarcinoma Drug: Ruxolitinib Drug: Placebo Drug: Capecitabine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase 3 Study of the Janus Kinase (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 1 Study)

Resource links provided by NLM:

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Randomization until death due to any cause. Approximately 21 months. ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 21 months. ]
    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.

  • Objective Response Rate (ORR) [ Time Frame: Baseline through end of study. Approximately 21 months. ]
    Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment

  • Duration of Response [ Time Frame: Baseline through end of study. Approximately 21 months. ]
    Duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment

  • Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments. [ Time Frame: Baseline through approximately 30 days post treatment discontinuation. Approximately 21 months. ]

Enrollment: 318
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib plus capecitabine Drug: Ruxolitinib
5 mg tablets to be administered by mouth twice daily [BID] 15 mg BID
Other Names:
  • Jakafi ®
  • Jakavi ®
Drug: Capecitabine
500 mg tablets to be administered by mouth twice daily [BID]
Active Comparator: Placebo plus capecitabine Drug: Placebo
500 mg tablets to be administered by mouth twice daily [BID]
Drug: Capecitabine
500 mg tablets to be administered by mouth twice daily [BID]

Detailed Description:

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

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

Treatment will consist of repeating 21-day cycles. Capecitabine will be self-administered for the first 14 days of each cycle, and ruxolitinib/placebo will be self-administered during the entire cycle. Treatment for all subjects will continue as long as the regimen is tolerated, and the subject does not meet discontinuation criteria. Subjects who discontinue treatment will continue to be followed for subsequent anticancer treatments and survival.


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

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 subjects must have recovered or be at a new stable baseline from any related toxicities.
  • Radiographically measurable or evaluable disease
  • An mGPS of 1 or 2 as defined below:

    • Criteria:

      • C-reactive protein >10 mg/L AND albumin ≥35 g/L; Score = 1
      • C-reactive protein >10 mg L AND albumin <35 g/L; Score = 2

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02117479

  Show 230 Study Locations
Sponsors and Collaborators
Incyte Corporation
Study Director: Fitzroy Dawkins, M.D. Incyte Corporation
  More Information

Responsible Party: Incyte Corporation Identifier: NCT02117479     History of Changes
Other Study ID Numbers: INCB 18424-362
Study First Received: April 16, 2014
Last Updated: October 3, 2016

Keywords provided by Incyte Corporation:
Metastatic pancreatic cancer
Metastatic pancreatic adenocarcinoma that is recurrent

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on June 26, 2017