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A Study of Ruxolitinib in Pancreatic Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02119663
Recruitment Status : Terminated (The safety committee found no safety issues but recommended halting the study based on a lack of efficacy in a similar trial. The sponsor terminated the trial.)
First Posted : April 22, 2014
Results First Posted : June 6, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Ruxolitinib Drug: Placebo Drug: Capecitabine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : October 2016


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: Placebo
5 mg matching placebo tablets to be administered by mouth twice daily (BID)

Drug: Capecitabine
150 mg or 500 mg tablets to be administered by mouth twice daily (BID)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119663


Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Fitzroy Dawkins, MD Incyte Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02119663    
Other Study ID Numbers: INCB 18424-363
First Posted: April 22, 2014    Key Record Dates
Results First Posted: June 6, 2017
Last Update Posted: February 13, 2018
Last Verified: January 2018
Keywords provided by Incyte Corporation:
Metastatic pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents