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Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Incyte Corporation
Information provided by (Responsible Party):
Incyte Corporation Identifier:
First received: April 16, 2014
Last updated: September 25, 2014
Last verified: September 2014

To determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of 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 (Subject, 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 21 months. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 310
Study Start Date: March 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (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

15 mg BID

Other Names:
  • Jakafi ®
  • Jakavi ®
Drug: Capecitabine
Capecitabine 2000 mg/m^2 daily (1000 mg/m^2 twice daily [BID])
Active Comparator: Placebo plus capecitabine Drug: Placebo
5 mg matching placebo tablets to be administered by mouth
Drug: Capecitabine
Capecitabine 2000 mg/m^2 daily (1000 mg/m^2 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 2000 mg/m^2 daily (1000 mg/m^2 twice daily [BID]) + ruxolitinib 15 mg BID
  • Treatment B (N = 155): Capecitabine 2000 mg/m^2 daily (1000 mg/m^2 BID) + placebo (administered BID)

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
Genders Eligible for Study:   Both
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

Exclusion Criteria:

  • Received more than 1 prior chemotherapy regimen for advanced or metastatic disease.
  • Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment, or prior history of radiation therapy to ≥ 25% of the bone marrow.
  • 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 sensitivity to fluorouracil (5-FU).
  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

Contact: Incyte Corporation Call Center 844-23JANUS

  Show 65 Study Locations
Sponsors and Collaborators
Incyte Corporation
Study Director: Fitzroy Dawkins, M.D. Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation Identifier: NCT02117479     History of Changes
Other Study ID Numbers: INCB 18424-362
Study First Received: April 16, 2014
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 20, 2014