Study of Ruxolitinib in Pancreatic Cancer Patients (RECAP)
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ClinicalTrials.gov Identifier: NCT01423604 |
Recruitment Status :
Completed
First Posted : August 26, 2011
Results First Posted : August 29, 2016
Last Update Posted : February 12, 2018
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Sponsor:
Incyte Corporation
Information provided by (Responsible Party):
Incyte Corporation
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Pancreatic Cancer |
Interventions |
Drug: Capecitabine Drug: Ruxolitinib Drug: Placebo |
Enrollment | 136 |
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 Details |
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 |
Reason Not Completed | ||
Adverse Event | 3 | 0 |
Death | 1 | 0 |
Physician Decision | 1 | 0 |
Disease progression | 3 | 0 |
Patient decision | 1 | 0 |
Period Title: Randomized | ||
Started | 64 | 63 |
Completed | 1 [1] | 0 |
Not Completed | 63 | 63 |
Reason Not Completed | ||
Adverse Event | 4 | 10 |
Death | 1 | 0 |
Physician Decision | 16 | 13 |
Other - unspecified | 37 | 31 |
Patient decision | 5 | 9 |
[1]
As of 07August2015, 1 subject was receiving treatment in the randomized portion.
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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 Number of Baseline Participants | 9 | 64 | 63 | 136 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 9 participants | 64 participants | 63 participants | 136 participants | |
61.6 (9.4) | 65.7 (9.3) | 66.3 (9.8) | 66.0 (9.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 64 participants | 63 participants | 136 participants | |
Female |
5 55.6%
|
23 35.9%
|
29 46.0%
|
57 41.9%
|
|
Male |
4 44.4%
|
41 64.1%
|
34 54.0%
|
79 58.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 64 participants | 63 participants | 136 participants | |
Hispanic or Latino |
0 0.0%
|
1 1.6%
|
5 7.9%
|
6 4.4%
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|
Not Hispanic or Latino |
9 100.0%
|
62 96.9%
|
58 92.1%
|
129 94.9%
|
|
Unknown or Not Reported |
0 0.0%
|
1 1.6%
|
0 0.0%
|
1 0.7%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 9 participants | 64 participants | 63 participants | 136 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
1 11.1%
|
0 0.0%
|
1 1.6%
|
2 1.5%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
3 33.3%
|
9 14.1%
|
6 9.5%
|
18 13.2%
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White |
5 55.6%
|
54 84.4%
|
54 85.7%
|
113 83.1%
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|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
1 1.6%
|
2 3.2%
|
3 2.2%
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Height
[1] Mean (Standard Deviation) Unit of measure: Cm |
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Number Analyzed | 9 participants | 64 participants | 63 participants | 136 participants | |
171.67 (14.11) | 171.29 (11.93) | 168.27 (10.25) | 169.78 (11.18) | ||
[1]
Measure Description: Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)
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Weight
[1] Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 9 participants | 64 participants | 63 participants | 136 participants | |
75.051 (17.317) | 75.014 (21.914) | 69.299 (16.260) | 72.156 (19.427) | ||
[1]
Measure Description: Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)
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Body mass index (BMI)
[1] Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 9 participants | 64 participants | 63 participants | 136 participants | |
25.3 (4.209) | 25.354 (6.332) | 24.243 (4.237) | 24.789 (5.394) | ||
[1]
Measure Description: Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)
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Body surface area
[1] Mean (Standard Deviation) Unit of measure: M^2 |
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Number Analyzed | 9 participants | 64 participants | 63 participants | 136 participants | |
1.869 (0.287) | 1.863 (0.297) | 1.791 (0.248) | 1.827 (0.275) | ||
[1]
Measure Description: Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT01423604 |
Other Study ID Numbers: |
18424-262 |
First Submitted: | August 22, 2011 |
First Posted: | August 26, 2011 |
Results First Submitted: | April 1, 2016 |
Results First Posted: | August 29, 2016 |
Last Update Posted: | February 12, 2018 |