Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02292446 |
|
Recruitment Status :
Completed
First Posted : November 17, 2014
Results First Posted : April 2, 2019
Last Update Posted : July 18, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Polycythemia Vera | Drug: Ruxolitinib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 161 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label, Multi-center, Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Are Available. |
| Actual Study Start Date : | November 21, 2014 |
| Actual Primary Completion Date : | December 29, 2017 |
| Actual Study Completion Date : | December 29, 2017 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: All patients
All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
|
Drug: Ruxolitinib
supplied as 5 mg, 10 mg and 20 mg tablets to be taken orally |
- Number of Participants With Adverse Events - All Grades [ Time Frame: Baseline up to approximately 26 months ]Summary of adverse events (all grades).
- Change From Baseline in Hematocrit Levels at All Visits [ Time Frame: Up to approximately 26 months ]Change in hematocrit levels from Baseline to each visit were measured
- Change From Baseline in Spleen Length [ Time Frame: Up to approximately 26 months ]Change in spleen length from Baseline to each visit
- Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) [ Time Frame: Up to approximately 26 months ]
The MPN-SAF (Appendix 6) was a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms including: early satiety, abdominal discomfort, inactivity, concentration, night sweats, itching, bone pain, fever and weight loss. There were three recall periods used in this questionnaire, which were 24 hours for fatigue, the past week for symptoms of early satiety, abdominal discomfort, inactivity, concentration, night sweats, itching, bone pain and fever, and the past 6 months for weight loss, Each item was scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable). The MPN-SAF TSS was computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale.
The MPN-SAF TSS thus had a possible score range of 0 to 100.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
•Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, palpable spleen, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2; did not have access to a comparable or satisfactory alternative treatment
Exclusion Criteria:
•Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, except treated cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin, with no evidence for recurrence in the past 3 years., Women who were pregnant or nursing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292446
Show 65 study locations
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02292446 |
| Other Study ID Numbers: |
CINC424B2001X |
| First Posted: | November 17, 2014 Key Record Dates |
| Results First Posted: | April 2, 2019 |
| Last Update Posted: | July 18, 2019 |
| Last Verified: | July 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Polycythemia Vera Hematologic Diseases Myeloproliferative Disorders INC424 |
Ruxolitinib hydroxyurea resistant adult |
|
Polycythemia Vera Polycythemia Hematologic Diseases Bone Marrow Neoplasms Hematologic Neoplasms |
Neoplasms by Site Neoplasms Bone Marrow Diseases Myeloproliferative Disorders |