Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.
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 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib plus capecitabine | Experimental |
| |
| Placebo plus capecitabine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | 5 mg tablets to be administered by mouth twice daily (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is reported here based on the number of deaths from randomization until the data cut-off. | Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fitzroy Dawkins, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29508247 | Derived | 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. |
Not provided
Not provided
Treatment was started as soon as possible after randomization (within 3 days) and consisted of continuous 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered for the entire cycle.
Participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were randomized in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib Plus Capecitabine | Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID). |
| FG001 | Placebo Plus Capecitabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 5 mg matching placebo tablets to be administered by mouth twice daily (BID) |
|
| Capecitabine | Drug | 150 mg or 500 mg tablets to be administered by mouth twice daily (BID) |
|
| 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. | 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. | 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. | 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). | Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016. |
| Fayetteville |
| Arkansas |
| United States |
| Beverly Hills | California | United States |
| La Jolla | California | United States |
| Aurora | Colorado | United States |
| Denver | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Fort Myers | Florida | United States |
| St. Petersburg | Florida | United States |
| Athens | Georgia | United States |
| Atlanta | Georgia | United States |
| Macon | Georgia | United States |
| Thomasville | Georgia | United States |
| Harvey | Illinois | United States |
| Indianapolis | Indiana | United States |
| Kansas City | Kansas | United States |
| Louisville | Kentucky | United States |
| Baltimore | Maryland | United States |
| Boston | Massachusetts | United States |
| Farmington Hills | Michigan | United States |
| Kalamazoo | Michigan | United States |
| Lansing | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Saint Louis Park | Minnesota | United States |
| Bolivar | Missouri | United States |
| Basking Ridge | New Jersey | United States |
| Cherry Hill | New Jersey | United States |
| Voorhees Township | New Jersey | United States |
| Commack | New York | United States |
| Fresh Meadows | New York | United States |
| Harrison | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Rockville Centre | New York | United States |
| Sleepy Hollow | New York | United States |
| Canton | Ohio | United States |
| Cincinnati | Ohio | United States |
| Portland | Oregon | United States |
| Allentown | Pennsylvania | United States |
| Hershey | Pennsylvania | United States |
| Langhorne | Pennsylvania | United States |
| Greenville | South Carolina | United States |
| Chattanooga | Tennessee | United States |
| Knoxville | Tennessee | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Lubbock | Texas | United States |
| San Antonio | Texas | United States |
| Temple | Texas | United States |
| Salt Lake City | Utah | United States |
| Falls Church | Virginia | United States |
| Newport News | Virginia | United States |
| Seattle | Washington | United States |
| Green Bay | Wisconsin | United States |
| Graz | Austria |
| Linz | Austria |
| Salzburg | Austria |
| Vienna | Austria |
| Wein | Austria |
| Santiago | Chile |
| Vitacura | Chile |
| Bogotá | Colombia |
| MedellÃn | Colombia |
| Næstved | Denmark |
| Odense C | Denmark |
| Bordeaux | France |
| Brest | France |
| Dijon | France |
| Lyon | France |
| Nancy | France |
| Cork | Ireland |
| Dubin | Ireland |
| Galway | Ireland |
| Beersheba | Israel |
| Haifa | Israel |
| Jerusalem | Israel |
| Petah Tikva | Israel |
| Ramat Gan | Israel |
| Tel Aviv | Israel |
| Tel Litwinsky | Israel |
| Monterrey | Mexico |
| Oaxaca City | Mexico |
| Toluca | Mexico |
| Amsterdam | Netherlands |
| Maastricht | Netherlands |
| Nijmegen | Netherlands |
| Braga | Portugal |
| Lisbon | Portugal |
| Porto | Portugal |
| San Juan | Puerto Rico |
| Linköping | Sweden |
| Uppsala | Sweden |
| Bellinzona | Switzerland |
| Geneva | Switzerland |
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib Plus Capecitabine | Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID). |
| BG001 | Placebo Plus Capecitabine | Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | Overall survival is reported here based on the number of deaths from randomization until the data cut-off. | The intent-to-treat (ITT) population consisted of all participants randomized to the study. | Posted | Count of Participants | Participants | Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The intent-to-treat (ITT) population consisted of all participants randomized to the study. | Posted | Median | 95% Confidence Interval | days | Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The intent-to-treat (ITT) population consisted of all participants randomized to the study. | Posted | Median | 95% Confidence Interval | percentage of participants | Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The intent-to-treat (ITT) population consisted of all participants randomized to the study. | Posted | Number | percentage of participants | Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The intent-to-treat (ITT) population consisted of all participants randomized to the study. | Posted | Median | 95% Confidence Interval | days | Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo). | Posted | Count of Participants | Participants | Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016. |
|
From the first dose of study medication through the double-blind period through study termination up to 6-months or to the data cutoff 11FEB2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ruxolitinib Plus Capecitabine | Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID). | 28 | 42 | 38 | 42 | ||
| EG001 | Placebo Plus Capecitabine | Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID). | 20 | 43 | 40 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
The study was terminated prior to the final analysis at the recommendation of the Data Monitoring Committee based on the review of efficacy in the 18424-362 (JANUS 1).
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 855 463-3463 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| > 65 years |
|
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|