RECAP: Study of Ruxolitinib in Pancreatic Cancer Patients
Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01423604
Collaborator
(none)
136
39
2
64.1
3.5
0.1
Study Details
Study Description
Brief Summary
The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The study consisted of an open-label, safety run-in period that was composed of 1 patient cohort with 9 patients/cohort. This phase of the study determined the safety of the capecitabine/ruxolitinib combination in this patient population.
A randomized, double-blind study with two treatment arms was conducted once the safety run-in results from the first part of the study showed that the capecitabine/ruxolitinib combination was safe and additional patients could be treated. All patients have received capecitabine therapy in addition to the ruxolitinib or placebo (Study Drug).
Treatment for all patients consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and the Study Drug was self-administered during the entire 21-day cycle. Treatment cycles continued as long as the regimen was tolerated and the patient did not meet any of the discontinuation criteria. In the event of disease progression, capecitabine therapy was discontinued but the Study Drug could continue to be administered. Subjects who discontinued treatment with the Study Drug continued to be followed to obtain information regarding subsequent treatment regimens and survival.
Study Design
Study Type:
Interventional
Actual Enrollment
:
136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 2 Study of Ruxolitinib Efficacy and Safety in Combination With Capecitabine for Subjects With Recurrent or Treatment Refractory Metastatic Pancreatic Cancer (The RECAP Trial)
Study Start Date
:
Jul 1, 2011
Actual Primary Completion Date
:
Jun 1, 2013
Actual Study Completion Date
:
Nov 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Capecitabine and ruxolitinib
|
Drug: Capecitabine
Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) (NOTE: Frequency of administration may be adjusted during the study.)
Drug: Ruxolitinib
Ruxolitinib starting dose - 15 mg BID (NOTE: Starting dose of randomized study drug may be 10 mg BID based on results from safety run-in study. Dose of ruxolitinib may be increased during randomized study.)
|
| Placebo Comparator: Capecitabine and placebo
|
Drug: Capecitabine
Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) (NOTE: Frequency of administration may be adjusted during the study.)
Drug: Placebo
Placebo matching ruxolitinib
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).]
Overall survival was measured as the length of time (in days) between the randomization date and the date of death.
Secondary Outcome Measures
- Progression-Free Survival (PFS) [Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.]
Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Objective Response Rate [Measured every 4 weeks for duration of study treatment (up to 8 months)]
Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Durable Response Rate [Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)]
Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart.
- Summary of Clinical Benefit [Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)]
A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria: Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
18 years of age or older
-
Diagnosis of metastatic pancreatic cancer; subjects must have had measurable, or evaluable disease that was histologically confirmed
-
Karnofsky performance status of ≥ 60
-
Subjects must have failed 1st-line gemcitabine treatment for metastatic pancreatic cancer:
o An alternate chemotherapeutic agent was an acceptable substitute as 1st-line therapy in the event that the subject was intolerant to or ineligible to receive gemcitabine
- ≥ 2 weeks elapsed from the completion of previous chemotherapy, and subjects must have recovered or been at new stable baseline from any related toxicities
Exclusion Criteria:
-
More than 1 prior chemotherapy regimen (not including adjuvant therapy) for metastatic disease
-
Evidence of central nervous system (CNS) metastases (unless stable for > 3 months) or history of uncontrolled seizures
-
Ongoing radiation therapy or prior radiation therapy administered as a second-line treatment
-
Other active malignancy except basal or squamous carcinoma of the skin
-
Inability to swallow food or any condition of the upper GI tract that precluded administration of oral medications
-
Inadequate renal, hepatic and bone marrow function demonstrated by clinical observations and/or laboratory assessments
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Hot Springs | Arkansas | United States | ||
| 3 | Burbank | California | United States | ||
| 4 | Los Angeles | California | United States | ||
| 5 | Santa Monica | California | United States | ||
| 6 | Denver | Colorado | United States | ||
| 7 | Stamford | Connecticut | United States | ||
| 8 | Boynton Beach | Florida | United States | ||
| 9 | Fort Myers | Florida | United States | ||
| 10 | Saint Petersburg | Florida | United States | ||
| 11 | Arlington Heights | Illinois | United States | ||
| 12 | Elks Grove Village | Illinois | United States | ||
| 13 | Indianapolis | Indiana | United States | ||
| 14 | Sioux City | Iowa | United States | ||
| 15 | Lexington | Kentucky | United States | ||
| 16 | Louisville | Kentucky | United States | ||
| 17 | Worcester | Massachusetts | United States | ||
| 18 | Ann Arbor | Michigan | United States | ||
| 19 | Detroit | Michigan | United States | ||
| 20 | Grand Rapids | Michigan | United States | ||
| 21 | Novi | Michigan | United States | ||
| 22 | Minneapolis | Minnesota | United States | ||
| 23 | Saint Louis | Missouri | United States | ||
| 24 | Voorhees | New Jersey | United States | ||
| 25 | Albuquerque | New Mexico | United States | ||
| 26 | Lake Success | New York | United States | ||
| 27 | Durham | North Carolina | United States | ||
| 28 | Hickory | North Carolina | United States | ||
| 29 | Canton | Ohio | United States | ||
| 30 | Dayton | Ohio | United States | ||
| 31 | Tulsa | Oklahoma | United States | ||
| 32 | Bend | Oregon | United States | ||
| 33 | Portland | Oregon | United States | ||
| 34 | Danville | Pennsylvania | United States | ||
| 35 | Pittsburgh | Pennsylvania | United States | ||
| 36 | Knoxville | Tennessee | United States | ||
| 37 | San Antonio | Texas | United States | ||
| 38 | Richmond | Virginia | United States | ||
| 39 | Green Bay | Wisconsin | United States |
Sponsors and Collaborators
- Incyte Corporation
Investigators
- Study Director: William Williams, MD, Incyte Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01423604
Other Study ID Numbers:
- 18424-262
First Posted:
Aug 26, 2011
Last Update Posted:
Feb 12, 2018
Last Verified:
Jan 1, 2018
Keywords provided by Incyte Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The open-label, safety run-in (1 cohort) was designed to confirm the safety of the combination of ruxolitinib and capecitabine in subjects with advanced or metastatic adenocarcinoma of the pancreas. The double-blind portion was 2 treatment groups randomized 1:1: ruxolitinib plus capecitabine or matching placebo plus capecitabine. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ruxolitinib | Placebo |
|---|---|---|
| Arm/Group Description | Part 1: Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) + ruxolitinib 15 mg BID. Part 2: Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). | Part 2: Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). |
| Period Title: Safety Run-In | ||
| STARTED | 9 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 9 | 0 |
| Period Title: Safety Run-In | ||
| STARTED | 64 | 63 |
| COMPLETED | 1 | 0 |
| NOT COMPLETED | 63 | 63 |
Baseline Characteristics
| Arm/Group Title | Ruxolitinib - Safety Run-In | Ruxolitinib | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]) + ruxolitinib at 15 mg BID. | Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). | Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). | Total of all reporting groups |
| Overall Participants | 9 | 64 | 63 | 136 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
61.6
(9.4)
|
65.7
(9.3)
|
66.3
(9.8)
|
66.0
(9.5)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
5
55.6%
|
23
35.9%
|
29
46%
|
57
41.9%
|
| Male |
4
44.4%
|
41
64.1%
|
34
54%
|
79
58.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
1
1.6%
|
5
7.9%
|
6
4.4%
|
| Not Hispanic or Latino |
9
100%
|
62
96.9%
|
58
92.1%
|
129
94.9%
|
| Unknown or Not Reported |
0
0%
|
1
1.6%
|
0
0%
|
1
0.7%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
11.1%
|
0
0%
|
1
1.6%
|
2
1.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
33.3%
|
9
14.1%
|
6
9.5%
|
18
13.2%
|
| White |
5
55.6%
|
54
84.4%
|
54
85.7%
|
113
83.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
1
1.6%
|
2
3.2%
|
3
2.2%
|
| Height (cm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cm] |
171.67
(14.11)
|
171.29
(11.93)
|
168.27
(10.25)
|
169.78
(11.18)
|
| Weight (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
75.051
(17.317)
|
75.014
(21.914)
|
69.299
(16.260)
|
72.156
(19.427)
|
| Body mass index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg/m^2] |
25.3
(4.209)
|
25.354
(6.332)
|
24.243
(4.237)
|
24.789
(5.394)
|
| Body surface area (m^2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [m^2] |
1.869
(0.287)
|
1.863
(0.297)
|
1.791
(0.248)
|
1.827
(0.275)
|
Outcome Measures
| Title | Overall Survival |
|---|---|
| Description | Overall survival was measured as the length of time (in days) between the randomization date and the date of death. |
| Time Frame | Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study. |
| Arm/Group Title | Ruxolitinib | Placebo |
|---|---|---|
| Arm/Group Description | Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). | Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). |
| Measure Participants | 64 | 63 |
| Median (95% Confidence Interval) [days] |
136.5
|
129.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ruxolitinib, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0494 |
| Comments | One-sided p-value. | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.733 | |
| Confidence Interval |
(2-Sided) 95% 0.506 to 1.061 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Ruxolitinib, Placebo |
|---|---|---|
| Comments | Cox Regression Analysis of Overall Survival: C-reactive protein (CRP) > 13 μg/ml; Statistical analysis plan (SAP) specified subgroup analysis | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0081 |
| Comments | One-sided p-value. | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.502 | |
| Confidence Interval |
(2-Sided) 95% 0.281 to 0.888 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Progression-Free Survival (PFS) |
|---|---|
| Description | Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Time Frame | Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study. |
| Arm/Group Title | Ruxolitinib | Placebo |
|---|---|---|
| Arm/Group Description | Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). | Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). |
| Measure Participants | 64 | 63 |
| Median (95% Confidence Interval) [days] |
51.0
|
46.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ruxolitinib, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1340 |
| Comments | Two-sided p-value. | |
| Method | Cox proportional hazards model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Efron approximation of hazard ratio |
| Estimated Value | 0.750 | |
| Confidence Interval |
(2-Sided) 95% 0.513 to 1.094 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Objective Response Rate |
|---|---|
| Description | Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Time Frame | Measured every 4 weeks for duration of study treatment (up to 8 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study. |
| Arm/Group Title | Ruxolitinib | Placebo |
|---|---|---|
| Arm/Group Description | Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). | Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). |
| Measure Participants | 64 | 63 |
| Overall response |
7.8
86.7%
|
1.6
2.5%
|
| Complete response |
1.6
17.8%
|
0.0
0%
|
| Partial response |
6.3
70%
|
1.6
2.5%
|
| Title | Durable Response Rate |
|---|---|
| Description | Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart. |
| Time Frame | Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study. |
| Arm/Group Title | Ruxolitinib | Placebo |
|---|---|---|
| Arm/Group Description | Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). | Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). |
| Measure Participants | 64 | 63 |
| Number [percentage of participants] |
7.8
86.7%
|
0.0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ruxolitinib, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0236 |
| Comments | ||
| Method | Pearson's chi-square test | |
| Comments | ||
| Title | Summary of Clinical Benefit |
|---|---|
| Description | A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria: Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation. |
| Time Frame | Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study. |
| Arm/Group Title | Ruxolitinib | Placebo |
|---|---|---|
| Arm/Group Description | Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). | Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). |
| Measure Participants | 64 | 63 |
| Subjects with clinical benefit |
12.5
138.9%
|
1.6
2.5%
|
| Pain intensity - Improved |
10.9
121.1%
|
1.6
2.5%
|
| Analgesic use - Improved |
4.7
52.2%
|
0.0
0%
|
| Karnofsky performance status - Improved |
3.1
34.4%
|
0.0
0%
|
| Body weight - Improved |
3.1
34.4%
|
0.0
0%
|
Adverse Events
| Time Frame | From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months). | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety evaluable population included all randomized subjects who received at least 1 dose of study drug. | |||||
| Arm/Group Title | Ruxolitinib (Safety Run-In) | Ruxolitinib | Placebo | |||
| Arm/Group Description | Subjects received capecitabine 2000 mg/m^2 daily (taken as 1000 mg/m2 twice daily [BID]) + ruxolitinib 15 mg BID | Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). | Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). | |||
All Cause Mortality |
||||||
| Ruxolitinib (Safety Run-In) | Ruxolitinib | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Ruxolitinib (Safety Run-In) | Ruxolitinib | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/9 (55.6%) | 32/59 (54.2%) | 35/60 (58.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 0/9 (0%) | 4/59 (6.8%) | 1/60 (1.7%) | |||
| Febrile neutropenia | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Cardiac disorders | ||||||
| Acute myocardial infarction | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Cardiorespiratory arrest | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Atrial fibrillation | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Myocardial infarction | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Eye disorders | ||||||
| Diplopia | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 2/9 (22.2%) | 2/59 (3.4%) | 5/60 (8.3%) | |||
| Diarrhoea | 1/9 (11.1%) | 2/59 (3.4%) | 1/60 (1.7%) | |||
| Large intestinal obstruction | 0/9 (0%) | 2/59 (3.4%) | 0/60 (0%) | |||
| Nausea | 1/9 (11.1%) | 2/59 (3.4%) | 5/60 (8.3%) | |||
| Ascites | 0/9 (0%) | 1/59 (1.7%) | 2/60 (3.3%) | |||
| Colitis | 0/9 (0%) | 1/59 (1.7%) | 1/60 (1.7%) | |||
| Colonic obstruction | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Constipation | 0/9 (0%) | 1/59 (1.7%) | 1/60 (1.7%) | |||
| Enteritis | 0/9 (0%) | 1/59 (1.7%) | 1/60 (1.7%) | |||
| Esophagitis | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Intestinal perforation | 0/9 (0%) | 1/59 (1.7%) | 1/60 (1.7%) | |||
| Obstruction gastric | 0/9 (0%) | 1/59 (1.7%) | 3/60 (5%) | |||
| Pancreatitis | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Rectal hemorrhage | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Vomiting | 2/9 (22.2%) | 1/59 (1.7%) | 5/60 (8.3%) | |||
| Abdominal distension | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Esophageal varices hemorrhage | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Fecaloma | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Hematemesis | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Necrotizing colitis | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Small intestinal obstruction | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Upper gastrointestinal hemorrhage | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Gastrointestinal Haemorrhage | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Intestinal Obstruction | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| General disorders | ||||||
| Performance status decreased | 0/9 (0%) | 2/59 (3.4%) | 1/60 (1.7%) | |||
| Pyrexia | 0/9 (0%) | 2/59 (3.4%) | 1/60 (1.7%) | |||
| Asthenia | 1/9 (11.1%) | 0/59 (0%) | 2/60 (3.3%) | |||
| Device occlusion | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Fatigue | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| General physical health deterioration | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Pain | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Mucosal Inflammation | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Hepatobiliary disorders | ||||||
| Bile duct obstruction | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Cholangitis | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Jaundice | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Infections and infestations | ||||||
| Pneumonia | 0/9 (0%) | 5/59 (8.5%) | 1/60 (1.7%) | |||
| Cellulitis | 0/9 (0%) | 1/59 (1.7%) | 1/60 (1.7%) | |||
| Diverticulitis | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Empyema | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Klebsiella bacteremia | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Sepsis | 1/9 (11.1%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Bacteremia | 0/9 (0%) | 0/59 (0%) | 4/60 (6.7%) | |||
| Pneumonia klebsiella | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Septic shock | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Urinary tract infection | 1/9 (11.1%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Staphylococcal Sepsis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Streptococcal Sepsis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Hip fracture | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Investigations | ||||||
| International normalized ratio increased | 1/9 (11.1%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Prothrombin Time Prolonged | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/9 (0%) | 3/59 (5.1%) | 2/60 (3.3%) | |||
| Hypoglycemia | 0/9 (0%) | 1/59 (1.7%) | 1/60 (1.7%) | |||
| Hyponatremia | 0/9 (0%) | 1/59 (1.7%) | 1/60 (1.7%) | |||
| Decreased appetite | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Diabetic ketoacidosis | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Failure to thrive | 1/9 (11.1%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Muscular weakness | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Cancer pain | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Nervous system disorders | ||||||
| Depressed level of consciousness | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Somnolence | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Syncope | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Transient ischemic attack | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Cerebrovascular accident | 1/9 (11.1%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Convulsion | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Psychiatric disorders | ||||||
| Confusional state | 0/9 (0%) | 1/59 (1.7%) | 1/60 (1.7%) | |||
| Mental status changes | 1/9 (11.1%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Renal and urinary disorders | ||||||
| Renal failure acute | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Renal failure | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnea | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Pleural effusion | 0/9 (0%) | 1/59 (1.7%) | 0/60 (0%) | |||
| Pulmonary embolism | 1/9 (11.1%) | 1/59 (1.7%) | 2/60 (3.3%) | |||
| Dyspnoea | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Surgical and medical procedures | ||||||
| Colostomy | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Vascular disorders | ||||||
| Hypotension | 1/9 (11.1%) | 1/59 (1.7%) | 2/60 (3.3%) | |||
| Peripheral arterial occlusive disease | 0/9 (0%) | 0/59 (0%) | 1/60 (1.7%) | |||
| Shock Haemorrhagic | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Ruxolitinib (Safety Run-In) | Ruxolitinib | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/9 (100%) | 57/59 (96.6%) | 59/60 (98.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 7/9 (77.8%) | 30/59 (50.8%) | 12/60 (20%) | |||
| Thrombocytopenia | 0/9 (0%) | 5/59 (8.5%) | 3/60 (5%) | |||
| Leukopenia | 3/9 (33.3%) | 3/59 (5.1%) | 2/60 (3.3%) | |||
| Neutropenia | 2/9 (22.2%) | 3/59 (5.1%) | 3/60 (5%) | |||
| Leukocytosis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Eye disorders | ||||||
| Dry eye | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 5/9 (55.6%) | 22/59 (37.3%) | 23/60 (38.3%) | |||
| Diarrhea | 4/9 (44.4%) | 22/59 (37.3%) | 17/60 (28.3%) | |||
| Nausea | 4/9 (44.4%) | 21/59 (35.6%) | 27/60 (45%) | |||
| Stomatitis | 3/9 (33.3%) | 16/59 (27.1%) | 8/60 (13.3%) | |||
| Vomiting | 5/9 (55.6%) | 14/59 (23.7%) | 21/60 (35%) | |||
| Constipation | 2/9 (22.2%) | 11/59 (18.6%) | 19/60 (31.7%) | |||
| Flatulence | 1/9 (11.1%) | 7/59 (11.9%) | 3/60 (5%) | |||
| Abdominal pain upper | 1/9 (11.1%) | 6/59 (10.2%) | 7/60 (11.7%) | |||
| Ascites | 1/9 (11.1%) | 6/59 (10.2%) | 10/60 (16.7%) | |||
| Abdominal discomfort | 0/9 (0%) | 2/59 (3.4%) | 3/60 (5%) | |||
| Dyspepsia | 0/9 (0%) | 2/59 (3.4%) | 6/60 (10%) | |||
| Gastroesophageal reflux disease | 1/9 (11.1%) | 2/59 (3.4%) | 5/60 (8.3%) | |||
| Abdominal distension | 0/9 (0%) | 1/59 (1.7%) | 3/60 (5%) | |||
| Obstruction gastric | 0/9 (0%) | 1/59 (1.7%) | 3/60 (5%) | |||
| Dysphagia | 2/9 (22.2%) | 0/59 (0%) | 0/60 (0%) | |||
| Dry mouth | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Food poisoning | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Gastrointestinal haemorrhage | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Intestinal obstruction | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Tongue pigmentation | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| General disorders | ||||||
| Fatigue | 2/9 (22.2%) | 29/59 (49.2%) | 26/60 (43.3%) | |||
| Pyrexia | 1/9 (11.1%) | 10/59 (16.9%) | 5/60 (8.3%) | |||
| Asthenia | 2/9 (22.2%) | 7/59 (11.9%) | 8/60 (13.3%) | |||
| Chills | 1/9 (11.1%) | 5/59 (8.5%) | 2/60 (3.3%) | |||
| Catheter site discharge | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Catheter site pain | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Chest pain | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Mucosal Inflammation | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Pain | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Suprapubic pain | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Temperature Intolerance | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Tenderness | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Hepatobiliary disorders | ||||||
| Portal Vein Thrombosis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Infections and infestations | ||||||
| Pneumonia | 0/9 (0%) | 6/59 (10.2%) | 3/60 (5%) | |||
| Candidiasis | 1/9 (11.1%) | 3/59 (5.1%) | 4/60 (6.7%) | |||
| Bacteremia | 0/9 (0%) | 0/59 (0%) | 4/60 (6.7%) | |||
| Bronchitis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Cellulitis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Nail Bed Infection | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Onychomycosis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Oral Candidiasis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Rhinitis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Sepsis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Staphylococcal Sepsis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Streptococcal Sepsis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Contusion | 0/9 (0%) | 4/59 (6.8%) | 3/60 (5%) | |||
| Open Wound | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Investigations | ||||||
| Weight decreased | 1/9 (11.1%) | 5/59 (8.5%) | 3/60 (5%) | |||
| Aspartate aminotransferase increased | 0/9 (0%) | 4/59 (6.8%) | 1/60 (1.7%) | |||
| Blood alkaline phosphatase increased | 2/9 (22.2%) | 4/59 (6.8%) | 3/60 (5%) | |||
| International normalized ratio increased | 1/9 (11.1%) | 3/59 (5.1%) | 4/60 (6.7%) | |||
| Platelet count decreased | 0/9 (0%) | 0/59 (0%) | 4/60 (6.7%) | |||
| Prothrombin Time Prolonged | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 2/9 (22.2%) | 12/59 (20.3%) | 20/60 (33.3%) | |||
| Dehydration | 5/9 (55.6%) | 12/59 (20.3%) | 10/60 (16.7%) | |||
| Edema peripheral | 3/9 (33.3%) | 7/59 (11.9%) | 6/60 (10%) | |||
| Hyponatremia | 0/9 (0%) | 6/59 (10.2%) | 2/60 (3.3%) | |||
| Edema | 2/9 (22.2%) | 4/59 (6.8%) | 2/60 (3.3%) | |||
| Hyperglycemia | 0/9 (0%) | 4/59 (6.8%) | 5/60 (8.3%) | |||
| Hypokalemia | 0/9 (0%) | 3/59 (5.1%) | 2/60 (3.3%) | |||
| Hypokalaemia | 3/9 (33.3%) | 0/59 (0%) | 0/60 (0%) | |||
| Failure to Thrive | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Hypoalbuminaemia | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Hypocalcaemia | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Hypomagnesaemia | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Hypophagia | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Hypophosphataemia | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Hypoproteinaemia | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Malnutrition | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 1/9 (11.1%) | 8/59 (13.6%) | 12/60 (20%) | |||
| Musculoskeletal pain | 0/9 (0%) | 4/59 (6.8%) | 1/60 (1.7%) | |||
| Muscle spasms | 1/9 (11.1%) | 3/59 (5.1%) | 1/60 (1.7%) | |||
| Pain in extremity | 0/9 (0%) | 3/59 (5.1%) | 3/60 (5%) | |||
| Arthralgia | 1/9 (11.1%) | 2/59 (3.4%) | 7/60 (11.7%) | |||
| Nervous system disorders | ||||||
| Dizziness | 1/9 (11.1%) | 7/59 (11.9%) | 5/60 (8.3%) | |||
| Peripheral sensory neuropathy | 0/9 (0%) | 6/59 (10.2%) | 3/60 (5%) | |||
| Neuropathy peripheral | 0/9 (0%) | 4/59 (6.8%) | 3/60 (5%) | |||
| Dysgeusia | 0/9 (0%) | 3/59 (5.1%) | 1/60 (1.7%) | |||
| Headache | 0/9 (0%) | 2/59 (3.4%) | 4/60 (6.7%) | |||
| Cerebrovascular Accident | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Convulsion | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Psychiatric disorders | ||||||
| Confusional state | 1/9 (11.1%) | 5/59 (8.5%) | 3/60 (5%) | |||
| Depression | 0/9 (0%) | 3/59 (5.1%) | 6/60 (10%) | |||
| Insomnia | 0/9 (0%) | 3/59 (5.1%) | 7/60 (11.7%) | |||
| Somnolence | 0/9 (0%) | 3/59 (5.1%) | 1/60 (1.7%) | |||
| Mental Status Changes | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Renal and urinary disorders | ||||||
| Urinary tract infection | 2/9 (22.2%) | 2/59 (3.4%) | 7/60 (11.7%) | |||
| Reproductive system and breast disorders | ||||||
| Testicular Oedema | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pulmonary embolism | 1/9 (11.1%) | 7/59 (11.9%) | 3/60 (5%) | |||
| Dyspnea | 0/9 (0%) | 5/59 (8.5%) | 11/60 (18.3%) | |||
| Cough | 1/9 (11.1%) | 4/59 (6.8%) | 4/60 (6.7%) | |||
| Upper respiratory tract infection | 1/9 (11.1%) | 2/59 (3.4%) | 3/60 (5%) | |||
| Dyspnoea | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Oropharyngeal Pain | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Pleurisy | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Pleural Effusion | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Upper Respiratory Tract Irritation | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Palmar-plantar erythrodysesthesia syndrome | 2/9 (22.2%) | 19/59 (32.2%) | 19/60 (31.7%) | |||
| Dry skin | 0/9 (0%) | 3/59 (5.1%) | 1/60 (1.7%) | |||
| Rash | 0/9 (0%) | 1/59 (1.7%) | 5/60 (8.3%) | |||
| Skin hyperpigmentation | 1/9 (11.1%) | 1/59 (1.7%) | 3/60 (5%) | |||
| Rash maculopapular | 0/9 (0%) | 0/59 (0%) | 3/60 (5%) | |||
| Blister | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Onycholysis | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Rash Maculo-Papular | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Skin Discolouration | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Skin Exfoliation | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Vascular disorders | ||||||
| Hypotension | 1/9 (11.1%) | 6/59 (10.2%) | 2/60 (3.3%) | |||
| Hemorrhoids | 0/9 (0%) | 3/59 (5.1%) | 0/60 (0%) | |||
| Orthostatic Hypotension | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
| Shock Haemorrhagic | 1/9 (11.1%) | 0/59 (0%) | 0/60 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Incyte Corporation |
| Phone | 1-855-463-3463 |
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01423604
Other Study ID Numbers:
- 18424-262
First Posted:
Aug 26, 2011
Last Update Posted:
Feb 12, 2018
Last Verified:
Jan 1, 2018