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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02955940
• Other study ID #: INCB 18424-270
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 30, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer (CRC)
• Lung Cancer
• Pancreatic Cancer

Intervention

Drug:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.