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Trial record 17 of 2143 for:    "Pancreatic cancer"

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
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type: Interventional
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ruxolitinib

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]).

Placebo 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]).

Participant Flow for 2 periods

Period 1:   Safety Run-In
    Ruxolitinib   Placebo
STARTED   9   0 
COMPLETED   0   0 
NOT COMPLETED   9   0 
Adverse Event                3                0 
Death                1                0 
Physician Decision                1                0 
Disease progression                3                0 
Patient decision                1                0 

Period 2:   Randomized
    Ruxolitinib   Placebo
STARTED   64   63 
COMPLETED   1 [1]   0 
NOT COMPLETED   63   63 
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.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ruxolitinib - Safety Run-In Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]) + ruxolitinib at 15 mg BID.
Ruxolitinib 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]).
Placebo 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 Total of all reporting groups

Baseline Measures
   Ruxolitinib - Safety Run-In   Ruxolitinib   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   64   63   136 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.6  (9.4)   65.7  (9.3)   66.3  (9.8)   66.0  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of 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% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      0   0.0%      1   1.6%      5   7.9%      6   4.4% 
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% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 
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% 
White      5  55.6%      54  84.4%      54  85.7%      113  83.1% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   1.6%      2   3.2%      3   2.2% 
Height [1] 
[Units: Cm]
Mean (Standard Deviation)
 171.67  (14.11)   171.29  (11.93)   168.27  (10.25)   169.78  (11.18) 
Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 75.051  (17.317)   75.014  (21.914)   69.299  (16.260)   72.156  (19.427) 
Body mass index (BMI) [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 25.3  (4.209)   25.354  (6.332)   24.243  (4.237)   24.789  (5.394) 
Body surface area [1] 
[Units: M^2]
Mean (Standard Deviation)
 1.869  (0.287)   1.863  (0.297)   1.791  (0.248)   1.827  (0.275) 


  Outcome Measures

1.  Primary:   Overall Survival   [ 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). ]

2.  Secondary:   Progression-Free Survival (PFS)   [ 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. ]

3.  Secondary:   Objective Response Rate   [ Time Frame: Measured every 4 weeks for duration of study treatment (up to 8 months) ]

4.  Secondary:   Durable Response Rate   [ Time Frame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months) ]

5.  Secondary:   Summary of Clinical Benefit   [ Time Frame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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     History of Changes
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