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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Pancreatic Cancer; Lung Cancer; Colorectal Cancer (CRC)
• Intervention / Treatment: Drug: Ruxolitinib; Drug: Capecitabine; Drug: Regorafenib

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland, 31-501
    • Sp Zoz Szpital Uniwersytecki W Krakowie Oddzial Kliniczny Hematologii
  • Lublin, Poland, 20-081
    • Samodzielny Publiczny Szpital Kliniczny
  • Warsaw, Poland, 02-776
    • Instytut Hematologii i Transfuzjologii
• United States
  • California
    • Santa Monica, California, United States, 90404
      • UCLA Healthcare Hematology-Oncology
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • New York
    • Clifton Park, New York, United States, 12065
      • New York Oncology Hematology Pc.
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas M. D. Anderson Cancer Center
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical Consultants Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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: Jakafi®; INCB018424
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: Jakafi®; INCB018424; 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and types of adverse events and serious adverse events	Subjects will be treated until disease progression or discontinuation criteria are met.	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.

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Peter Langmuir, MD, Incyte Corporation

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimated): November 4, 2016

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: capecitabine; Solid tumors; regorafenib; ruxolitinib
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Lung Neoplasms; Colorectal Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine; ruxolitinib; regorafenib
• Other Study ID Numbers: INCB 18424-270; 2023-507225-42-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP