Clinical trial NCT02955940: An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
Official title: An Open-Label, Multicenter, Rollover Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Colorectal Cancer (CRC)
Breast Cancer
Lung Cancer
Keywords: Solid tumors
ruxolitinib
regorafenib
capecitabine
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2016-11-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Frequency and types of adverse events and serious adverse events
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA Healthcare Hematology-Oncology
state: California
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Clifton Park
country: United States
facility: New York Oncology Hematology Pc.
state: New York
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Houston
country: United States
facility: University of Texas M. D. Anderson Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical Consultants Llc
state: Texas
city: Krakow
country: Poland
facility: Sp Zoz Szpital Uniwersytecki W Krakowie Oddzial Kliniczny Hematologii
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny
city: Warszawa
country: Poland
facility: Instytut Hematologii I Transfuzjologii
Study officials:
affiliation: Incyte Corporation
name: Peter Langmuir, MD
role: STUDY_DIRECTOR
References: