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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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)
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)
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)
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
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)
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
321
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Australian Capital Territory
Recruitment hospital [2] 0 0
- New South Wales
Recruitment hospital [3] 0 0
- South Australia
Recruitment hospital [4] 0 0
- Victoria
Recruitment postcode(s) [1] 0 0
- Australian Capital Territory
Recruitment postcode(s) [2] 0 0
- New South Wales
Recruitment postcode(s) [3] 0 0
- South Australia
Recruitment postcode(s) [4] 0 0
- Victoria
Recruitment outside Australia
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Arizona
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Arkansas
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Delaware
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Harlow
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Huddersfield
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Lancaster
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Sutton
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Welwyn Garden City
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02117479