Pancreatic CancerPhase 2NCT02955940
An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
A Phase 2 study testing Ruxolitinib, Capecitabine and Regorafenib in people with Pancreatic Cancer and Colorectal Cancer (CRC), run by Incyte Corporation at 9 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Colorectal Cancer (CRC), Breast Cancer
- What is being tested?
- Ruxolitinib, Capecitabine and Regorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 30 Nov 2016to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
New York Oncology Hematology Pc.
Clifton Park, New York, 12065
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
University of Louisville
Louisville, Kentucky, 40202
Tennessee Oncology
Nashville, Tennessee, 37203
UCLA Healthcare Hematology-Oncology
Santa Monica, California, 90404
Renovatio Clinical Consultants Llc
The Woodlands, Texas, 77380
Poland3 sites
Sp Zoz Szpital Uniwersytecki W Krakowie Oddzial Kliniczny Hematologii
Krakow, 31-501
Samodzielny Publiczny Szpital Kliniczny
Lublin, 20-081
Instytut Hematologii I Transfuzjologii
Warsaw, 02-776
About this study
Official title: An Open-Label, Multicenter, Rollover Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
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.
- Conditions
- Pancreatic Cancer, Colorectal Cancer (CRC), Breast Cancer, Lung Cancer
- Being tested
- Ruxolitinib, Capecitabine, Regorafenib
- Keywords
- Solid tumors, ruxolitinib, regorafenib, capecitabine
- Medical subject headings
- Pancreatic Neoplasms, Colorectal Neoplasms, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called INCB018424, Jakafi®
5 mg BID
CapecitabineDrug
Also called Xeloda®
Capecitabine at the same dose provided in the parent study at the time of the rollover.
RegorafenibDrug
Also called Stivarga®
Regorafenib at the same dose provided in the parent study at the time of the rollover.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib | Experimental | 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. Receives: Drug: Ruxolitinib |
| Ruxolitinib plus background cancer therapy | Experimental | 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. Receives: Drug: Ruxolitinib; Drug: Capecitabine; Drug: Regorafenib |
| Background cancer therapy alone | Experimental | Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover. Receives: Drug: Capecitabine; Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and types of adverse events and serious adverse events
Subjects will be treated until disease progression or discontinuation criteria are met.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start30 Nov 2016
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Langmuir, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955940
- Sponsor's protocol ID
- INCB 18424-270
- Other IDs
- 2023-507225-42-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 3 Nov 2016
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Rollover Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
- ClinicalTrials.gov ID
- NCT02955940
- Acronym / sponsor ID
- INCB 18424-270
- Conditions
- Pancreatic Cancer, Colorectal Cancer (CRC), Breast Cancer, Lung Cancer
- Keywords
- Solid tumors, ruxolitinib, regorafenib, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib | Experimental | Drug: RuxolitinibStudy 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. |
| Ruxolitinib plus background cancer therapy | Experimental | Drug: Ruxolitinib, Drug: Capecitabine, Drug: RegorafenibStudy 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. |
| Background cancer therapy alone | Experimental | Drug: Capecitabine, Drug: RegorafenibCapecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: INCB018424, Jakafi®5 mg BID | Drug | Ruxolitinib, Ruxolitinib plus background cancer therapy |
| CapecitabineAlso: Xeloda®Capecitabine at the same dose provided in the parent study at the time of the rollover. | Drug | Background cancer therapy alone, Ruxolitinib plus background cancer therapy |
| RegorafenibAlso: Stivarga®Regorafenib at the same dose provided in the parent study at the time of the rollover. | Drug | Background cancer therapy alone, Ruxolitinib plus background cancer therapy |
Primary outcome
Frequency and types of adverse events and serious adverse events
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of RuxolitinibLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Langmuir, MD study director
Incyte Corporation
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib, Capecitabine and Regorafenib in people with Pancreatic Cancer and Colorectal Cancer (CRC), run by Incyte Corporation at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and types of adverse events and serious adverse events (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.