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

Sponsor
Incyte Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02955940
Collaborator
(none)
9
Enrollment
6
Locations
3
Arms
73
Anticipated Duration (Months)
1.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
9 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
Actual Study Start Date :
Nov 30, 2016
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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 Names:
  • Xeloda®

    • Drug: Regorafenib
    Regorafenib at the same dose provided in the parent study at the time of the rollover.
    Other Names:
  • 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 Names:
  • Xeloda®

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Frequency and types of adverse events and serious adverse events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Healthcare Hematology-Oncology Santa Monica California United States 90404
    2 University of Louisville Louisville Kentucky United States 40202
    3 New York Oncology Hematology Pc. Clifton Park New York United States 12065
    4 Tennessee Oncology Nashville Tennessee United States 37203
    5 Renovatio Clinical Houston Texas United States 77005
    6 University of Texas, Md Anderson Cancer Houston Texas United States 77030

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Peter Langmuir, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02955940
    Other Study ID Numbers:
    • INCB 18424-270
    First Posted:
    Nov 4, 2016
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Incyte Corporation
    Solid tumors
    ruxolitinib
    regorafenib
    capecitabine
    Additional relevant MeSH terms:
    Capecitabine

    Study Results

    No Results Posted as of Jul 8, 2022