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An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02955940
Recruitment Status : Enrolling by invitation
First Posted : November 4, 2016
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:

The purpose of this study is to provide continued supply of ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone to subjects from an Incyte-sponsored study of ruxolitinib that has reached its study objectives or has been terminated.

This study will also provide another mechanism for reporting adverse events related to study drug safety.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Colorectal Cancer (CRC) Breast Cancer Lung Cancer Drug: Ruxolitinib Drug: Capecitabine Drug: Regorafenib Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Rollover Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
Study Start Date : November 2016
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023


Arm Intervention/treatment
Experimental: Ruxolitinib
Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted.
Drug: Ruxolitinib
5 mg BID
Other Names:
  • INCB018424
  • Jakafi®

Experimental: Ruxolitinib plus background cancer therapy
Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted.
Drug: Ruxolitinib
5 mg BID
Other Names:
  • INCB018424
  • Jakafi®

Drug: Capecitabine
Capecitabine at the same dose provided in the parent study at the time of the rollover.
Other Name: Xeloda®

Drug: Regorafenib
Regorafenib at the same dose provided in the parent study at the time of the rollover.
Other Name: Stivarga®

Experimental: Background cancer therapy alone
Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover.
Drug: Capecitabine
Capecitabine at the same dose provided in the parent study at the time of the rollover.
Other Name: Xeloda®

Drug: Regorafenib
Regorafenib at the same dose provided in the parent study at the time of the rollover.
Other Name: Stivarga®




Primary Outcome Measures :
  1. Frequency and types of adverse events and serious adverse events [ Time Frame: Maximum duration of every 2 months (maximum duration of 1 month for subjects receiving regorafenib) from enrollment through 30-37 days after end of treatment up to 24 months. ]
    Subjects will be treated until disease progression or discontinuation criteria are met.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of ruxolitinib that has completed or been terminated.
  • Currently tolerating treatment in the parent protocol.
  • Currently benefiting from the treatment with ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone, as determined by the investigator.
  • Have at least stable disease, as determined by the investigator.
  • Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.

Exclusion Criteria:

  • Has been permanently discontinued from study treatment in the parent study for any reason.
  • Able to access ruxolitinib and/or background cancer therapy outside of the clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955940


Locations
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United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, New York
New York Oncology Hematology PC
Hudson, New York, United States, 12534
United States, Texas
U of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Fitzroy Dawkins, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02955940    
Other Study ID Numbers: INCB 18424-270
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Incyte Corporation:
Solid tumors
ruxolitinib
regorafenib
capecitabine
Additional relevant MeSH terms:
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Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents