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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Ruxolitinib
* Drug: Capecitabine
* Drug: Regorafenib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ruxolitinib<br>Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted. | Drug: Ruxolitinib<br>* 5 mg BID<br>* Other names: Jakafi®;|
| Experimental: Ruxolitinib plus background cancer therapy<br>Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted. | Drug: Ruxolitinib<br>* 5 mg BID<br>* Other names: Jakafi®;Drug: Capecitabine<br>* Capecitabine at the same dose provided in the parent study at the time of the rollover.<br>* Other names: Xeloda®;Drug: Regorafenib<br>* Regorafenib at the same dose provided in the parent study at the time of the rollover.<br>* Other names: Stivarga®;|
| Experimental: Background cancer therapy alone<br>Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover. | Drug: Capecitabine<br>* Capecitabine at the same dose provided in the parent study at the time of the rollover.<br>* Other names: Xeloda®;Drug: Regorafenib<br>* Regorafenib at the same dose provided in the parent study at the time of the rollover.<br>* Other names: Stivarga®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumors, ruxolitinib, regorafenib, capecitabine