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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02955940

Enrollment

Registered

2016-11-04

Start date

2016-11-30

Completion date

2027-09-30

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Solid tumors, ruxolitinib, regorafenib, capecitabine

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.

Interventions

DRUGRuxolitinib

5 mg BID

DRUGCapecitabine

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

DRUGRegorafenib

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Poland, United States

Contacts

STUDY_DIRECTORPeter Langmuir, MD

Incyte Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026