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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507225-42-00 | Registry Identifier | EU CT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Background cancer therapy alone | Experimental | Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | 5 mg BID |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Langmuir, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Healthcare Hematology-Oncology | Santa Monica | California | 90404 | United States | ||
| University of Louisville |
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| Label | URL |
|---|---|
| An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib | View source |
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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
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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| Capecitabine | Drug | Capecitabine at the same dose provided in the parent study at the time of the rollover. |
|
|
| Regorafenib | Drug | Regorafenib at the same dose provided in the parent study at the time of the rollover. |
|
|
| Louisville |
| Kentucky |
| 40202 |
| United States |
| New York Oncology Hematology Pc. | Clifton Park | New York | 12065 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| University of Texas M. D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Renovatio Clinical Consultants Llc | The Woodlands | Texas | 77380 | United States |
| Sp Zoz Szpital Uniwersytecki W Krakowie Oddzial Kliniczny Hematologii | Krakow | 31-501 | Poland |
| Samodzielny Publiczny Szpital Kliniczny | Lublin | 20-081 | Poland |
| Instytut Hematologii I Transfuzjologii | Warsaw | 02-776 | Poland |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D000069287 | Capecitabine |
| C559147 | regorafenib |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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