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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02117479




Registration number
NCT02117479
Ethics application status
Date submitted
16/04/2014
Date registered
21/04/2014
Date last updated
26/03/2019

Titles & IDs
Public title
Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)
Scientific title
A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 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)
Secondary ID [1] 0 0
INCB 18424-362
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ruxolitinib
Treatment: Drugs - Placebo
Treatment: Drugs - Capecitabine

Experimental: Ruxolitinib plus capecitabine -

Active Comparator: Placebo plus capecitabine -


Treatment: Drugs: Ruxolitinib
5 mg tablets to be administered by mouth twice daily (BID)

Treatment: Drugs: Placebo
5 mg tablets to be administered by mouth twice daily (BID)

Treatment: Drugs: Capecitabine
150 and 500 mg tablets to be administered by mouth twice daily (BID)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
Timepoint [1] 0 0
Randomization until death due to any cause; up to the data cutoff 11FEB2016.
Secondary outcome [1] 0 0
Progression-free Survival (PFS) - 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.
Timepoint [1] 0 0
Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Secondary outcome [2] 0 0
Percentage of Participants Achieving Progression Free Survival (PFS) - 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.
Timepoint [2] 0 0
Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Secondary outcome [3] 0 0
Objective Response Rate (ORR) - Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (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.
Timepoint [3] 0 0
Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Secondary outcome [4] 0 0
Duration of Response - 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.
Timepoint [4] 0 0
Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Secondary outcome [5] 0 0
Participants With Treatment-Emergent Adverse Events (TEAEs) - 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).
Timepoint [5] 0 0
Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.

Eligibility
Key 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

- Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

1. mGPS of 1: C-reactive protein >10 mg/L and albumin =35 g/L

2. mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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- South Australia
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- Victoria
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine
for the treatment of advanced or metastatic pancreatic cancer.
Trial website
https://clinicaltrials.gov/show/NCT02117479
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fitzroy Dawkins, M.D.
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02117479