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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Incyte Corporation
Study ID
NCT02955940
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    5 mg BID
  • Capecitabine — DRUG
    Capecitabine at the same dose provided in the parent study at the time of the rollover.
  • Regorafenib — DRUG
    Regorafenib at the same dose provided in the parent study at the time of the rollover.

Study Details

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.

Key Dates

Start date
Nov 30, 2016
Status verified
Dec 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • Experimental: Background cancer therapy alone
    Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover.

Primary Outcome Measure

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. ]

Locations (6)

FacilityCityStateZIPSite coordinators
UCLA Healthcare Hematology-OncologySanta MonicaCalifornia90404-
University of LouisvilleLouisvilleKentucky40202-
New York Oncology Hematology Pc.Clifton ParkNew York12065-
Tennessee OncologyNashvilleTennessee37203-
University of Texas M. D. Anderson Cancer CenterHoustonTexas77030-
Renovatio Clinical Consultants LlcThe WoodlandsTexas77380-

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UCLA Healthcare Hematology-Oncology· Santa Monica, CAUniversity of Louisville· Louisville, KYNew York Oncology Hematology Pc.· Clifton Park, NYTennessee Oncology· Nashville, TNUniversity of Texas M. D. Anderson Cancer Center· Houston, TXRenovatio Clinical Consultants Llc· The Woodlands, TX

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