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Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02117479
First received: April 16, 2014
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 ClinicalTrials.gov identifier: NCT02117479

Contacts
Contact: Incyte Corporation Call Center 844-23JANUS

Locations
United States, Florida
Recruiting
Miami, Florida, United States
United States, Georgia
Recruiting
Marietta, Georgia, United States
United States, Illinois
Recruiting
Arlington Heights, Illinois, United States
United States, Kansas
Recruiting
Topeka, Kansas, United States
United States, Kentucky
Recruiting
Ashland, Kentucky, United States
United States, Minnesota
Recruiting
Woodbury, Minnesota, United States
United States, Nebraska
Recruiting
Omaha, Nebraska, United States
United States, Nevada
Recruiting
Las Vegas, Nevada, United States
United States, New York
Recruiting
Hudson, New York, United States
United States, Oregon
Recruiting
Eugene, Oregon, United States
Recruiting
Portland, Oregon, United States
United States, Texas
Recruiting
Arlington, Texas, United States
Recruiting
Beaumont, Texas, United States
Recruiting
Bedford, Texas, United States
Recruiting
Dallas, Texas, United States
Recruiting
Denton, Texas, United States
Recruiting
Plano, Texas, United States
Recruiting
Round Rock, Texas, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Fitzroy Dawkins, M.D. Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02117479     History of Changes
Other Study ID Numbers: INCB 18424-362
Study First Received: April 16, 2014
Last Updated: May 29, 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
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014