An Open-Label 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cancer Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer (CRC) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sp Zoz Szpital Uniwersytecki W Krakowie Oddzial Kliniczny Hematologii, Krakow, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ruxolitinib

Drug

5 mg BID

Other names: INCB018424, Jakafi®

Capecitabine

Drug

Capecitabine at the same dose provided in the parent study at the time of the rollover.

Other names: Xeloda®

regorafenib

Drug

Regorafenib at the same dose provided in the parent study at the time of the rollover.

Other names: Stivarga®

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2027
Study completion: 2027
First posted: Nov 4, 2016
Registry last updated: Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed