Pancreatic CancerPhase 3NCT02119663
A Study of Ruxolitinib in Pancreatic Cancer Patients
A Phase 3 study testing Ruxolitinib and Capecitabine in people with Pancreatic Cancer, run by Incyte Corporation at 95 sites in 14 countries.
Trial summary
This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Ruxolitinib and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 95 sitesin 14 countries
- Study dates
- Jun 2014to Oct 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
- Criteria:
- mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ≥ 35 g/L
- mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L
Who cannot join
- 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.
Trial locations and contacts
95 sites in 14 countries.
95 sites in 14 countries
United States55 sites
Study site
Allentown, Pennsylvania
Study site
Athens, Georgia
Study site
Atlanta, Georgia
Study site
Aurora, Colorado
Study site
Baltimore, Maryland
Study site
Basking Ridge, New Jersey
Study site
Beverly Hills, California
Study site
Bolivar, Missouri
Study site
Boston, Massachusetts
Study site
Canton, Ohio
Study site
Chattanooga, Tennessee
Study site
Cherry Hill, New Jersey
Study site
Cincinnati, Ohio
Study site
Commack, New York
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Falls Church, Virginia
Study site
Farmington Hills, Michigan
Study site
Fayetteville, Arkansas
Study site
Fort Myers, Florida
Study site
Fort Worth, Texas
Study site
Fresh Meadows, New York
Study site
Green Bay, Wisconsin
Study site
Greenville, South Carolina
Study site
Harrison, New York
Study site
Harvey, Illinois
Study site
Hershey, Pennsylvania
Study site
Huntsville, Alabama
Study site
Indianapolis, Indiana
Study site
Kalamazoo, Michigan
Study site
Kansas City, Kansas
Study site
Knoxville, Tennessee
Study site
La Jolla, California
Study site
Langhorne, Pennsylvania
Study site
Lansing, Michigan
Study site
Louisville, Kentucky
Study site
Lubbock, Texas
Study site
Macon, Georgia
Study site
Minneapolis, Minnesota
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Newport News, Virginia
Study site
Portland, Oregon
Study site
Rochester, New York
Study site
Rockville Centre, New York
Study site
Saint Louis Park, Minnesota
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Seattle, Washington
Study site
Sleepy Hollow, New York
Study site
St. Petersburg, Florida
Study site
Temple, Texas
Study site
Thomasville, Georgia
Study site
Voorhees Township, New Jersey
Study site
Washington D.C., District of Columbia
Israel7 sites
Study site
Beersheba
Study site
Haifa
Study site
Jerusalem
Study site
Petah Tikva
Study site
Ramat Gan
Study site
Tel Aviv
Study site
Tel HaShomer
Austria5 sites
Study site
Graz
Study site
Linz
Study site
Salzburg
Study site
Vienna
Study site
Wein
France5 sites
Study site
Bordeaux
Study site
Brest
Study site
Dijon
Study site
Lyon
Study site
Nancy
Netherlands3 sites
Study site
Amsterdam
Study site
Maastricht
Study site
Nijmegen
About this study
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)
This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Ruxolitinib, Placebo, Capecitabine
- Keywords
- Metastatic pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called Jakafi ®, Jakavi ®
5 mg tablets to be administered by mouth twice daily (BID)
PlaceboDrug
5 mg matching placebo tablets to be administered by mouth twice daily (BID)
CapecitabineDrug
150 mg or 500 mg tablets to be administered by mouth twice daily (BID)
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib plus capecitabine | Experimental | Not described Receives: Drug: Ruxolitinib; Drug: Capecitabine |
| Placebo plus capecitabine | Active comparator | Not described Receives: Drug: Placebo; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival is reported here based on the number of deaths from randomization until the data cut-off.
Measured: Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016.
Secondary outcomes (5)
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 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.
Measured: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
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.
Measured: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Objective Response Rate (ORR)
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.
Measured: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
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. 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.
Measured: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
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).
Measured: Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2016
- Study completionOct 2016
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fitzroy Dawkins, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119663
- Sponsor's protocol ID
- INCB 18424-363
- Status last verified
- Jan 2018
- First submitted
- 17 Apr 2014
- Last updated
- 13 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hurwitz H, Van Cutsem E, Bendell J, Hidalgo M, Li CP, Salvo MG, Macarulla T, Sahai V, Sama A, Greeno E, Yu KH, Verslype C, Dawkins F, Walker C, Clark J, O'Reilly EM. Ruxolitinib + capecitabine in advanced/metastatic pancreatic cancer after disease progression/intolerance to first-line therapy: JANUS 1 and 2 randomized phase III studies. Invest New Drugs. 2018 Aug;36(4):683-695. doi: 10.1007/s10637-018-0580-2. Epub 2018 Mar 6.
PubMed 29508247
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02119663
- Acronym / sponsor ID
- INCB 18424-363
- Conditions
- Pancreatic Cancer
- Keywords
- Metastatic pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib plus capecitabine | Experimental | Drug: Ruxolitinib, Drug: Capecitabine |
| Placebo plus capecitabine | Active comparator | Drug: Placebo, Drug: Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: Jakafi ®, Jakavi ®5 mg tablets to be administered by mouth twice daily (BID) | Drug | Ruxolitinib plus capecitabine |
| Placebo5 mg matching placebo tablets to be administered by mouth twice daily (BID) | Drug | Placebo plus capecitabine |
| Capecitabine150 mg or 500 mg tablets to be administered by mouth twice daily (BID) | Drug | Placebo plus capecitabine, Ruxolitinib plus capecitabine |
Primary outcome
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.
5 secondary outcomes
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.
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.
Objective Response Rate (ORR)
Time frame: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Duration of Response
Time frame: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29508247Hurwitz H, Van Cutsem E, Bendell J, Hidalgo M, Li CP, Salvo MG, Macarulla T, Sahai V, Sama A, Greeno E, Yu KH, Verslype C, Dawkins F, Walker C, Clark J, O'Reilly EM. Ruxolitinib + capecitabine in advanced/metastatic pancreatic cancer after disease progression/intolerance to first-line therapy: JANUS 1 and 2 randomized phase III studies. Invest New Drugs. 2018 Aug;36(4):683-695. doi: 10.1007/s10637-018-0580-2. Epub 2018 Mar 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fitzroy Dawkins, MD study director
Incyte Corporation
95 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ruxolitinib and Capecitabine in people with Pancreatic Cancer, run by Incyte Corporation at 95 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States, Israel, Austria, France, Ireland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02119663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.