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Clinical Trials in Poland / NCT02955940
Active, not recruiting Phase 2

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

NCT02955940 · tracked via the Priya Life Science Poland tracker
Sponsor
Incyte Corporation
Phase
Phase 2
Started
2016-11-30
Last updated
2026-08-17

Condition(s) studied

Pancreatic CancerColorectal Cancer (CRC)Breast CancerLung Cancer

Investigational drug(s) / intervention(s)

Ruxolitinib →Capecitabine →Regorafenib →

Ruxolitinib: 5 mg BID

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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.

Trial sites (9)

FacilityCityRegionStatus
UCLA Healthcare Hematology-Oncology Santa Monica California
University of Louisville Louisville Kentucky
New York Oncology Hematology Pc. Clifton Park New York
Tennessee Oncology Nashville Tennessee
University of Texas M. D. Anderson Cancer Center Houston Texas
Renovatio Clinical Consultants Llc The Woodlands Texas
Sp Zoz Szpital Uniwersytecki W Krakowie Oddzial Kliniczny Hematologii Krakow Poland
Samodzielny Publiczny Szpital Kliniczny Lublin Poland
Instytut Hematologii I Transfuzjologii Warsaw Poland

On this site

📄 Jakafi (ruxolitinib) drug profile → 📄 Stivarga (regorafenib) drug profile →

More Incyte Corporation trials in Poland

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1) Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer Recruiting
A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia Recruiting
A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa Active, not recruiting
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis Active, not recruiting

Other trials for the same condition

A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy Active, not recruiting
Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. Active, not recruiting
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02955940 on ClinicalTrials.gov ↗ ← All trials in Poland