An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
Status and phase
Active, not recruiting
Phase 2
Conditions
Breast Cancer
Colorectal Cancer (CRC)
Lung Cancer
Pancreatic Cancer
Treatments
Drug: Regorafenib
Drug: Capecitabine
Drug: Ruxolitinib
Details and patient eligibility
About
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.
Enrollment
10 patients
Sex
All
Ages
18+ years old
Volunteers
No 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.
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
10 participants in 3 patient groups
Ruxolitinib
Experimental group
Description:
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.
Treatment:
Drug: Ruxolitinib
Ruxolitinib plus background cancer therapy
Experimental group
Description:
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.
Treatment:
Drug: Ruxolitinib
Drug: Capecitabine
Drug: Regorafenib
Background cancer therapy alone
Experimental group
Description:
Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover.
Treatment:
Drug: Capecitabine
Drug: Regorafenib
Trial contacts and locations
9
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Data sourced from clinicaltrials.gov
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