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The study was terminated due to low enrollment.
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The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after treatment interruption due to loss of response and/or adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib | Experimental | All participants received ruxolitinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Starting dose was based on reason for previous discontinuation of ruxolitinib (i.e. loss of response or AE) and baseline platelet count. For participants who previously discontinued ruxolitinib due to loss of response, the starting dose was determined based on baseline platelet counts as follows: participants with a baseline platelet count of ≥ 200 x 109/L began dosing at 20 mg po bid; participants with a baseline platelet count of 100 x 109/L to <200 x 109/L began dosing at 15 mg po bid. Participants who previously discontinued ruxolitinib due to an AE initiated therapy at a total daily dose 5 mg lower than the total daily dose prior to discontinuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving ≥20% Reduction From Baseline in Spleen Volume | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving ≥35% Reduction From Baseline in Spleen Volume | Week 24 | |
| Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively From Baseline, in Spleen Length | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Leipzig | 04103 | Germany | |||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib | All participants received ruxolitinib. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Change From Baseline in Spleen Length and Spleen Volume | Baseline, Week 24 |
| Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively, From Baseline in Total Symptom Score (MPN-SAF TSS) | Week 24 |
| Change From Baseline in MPN-SAF TSS Score | Baseline, Week 24 |
| Patient Global Impression of Change (PGIC) Score | Week 1, Week 24 |
| Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQol (EQ)-5D-5L Scores | Baseline, Day 1, Week 8, Week 12, Week 16, Week 24 |
| Florence |
| FI |
| 50134 |
| Italy |
| Novartis Investigative Site | Madrid | Madrid | 28034 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib | All participants received ruxolitinib. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Achieving ≥20% Reduction From Baseline in Spleen Volume | The study was terminated early due to low enrollment. Analysis was not done. | Posted | Week 24 |
|
| ||||||||||||||||||||
| Secondary | Proportion of Patients Achieving ≥35% Reduction From Baseline in Spleen Volume | The study was terminated early due to low enrollment. Analysis was not done. | Posted | Week 24 |
|
| ||||||||||||||||||||
| Secondary | Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively From Baseline, in Spleen Length | The study was terminated early due to low enrollment. Analysis was not done. | Posted | Week 24 |
|
| ||||||||||||||||||||
| Secondary | Change From Baseline in Spleen Length and Spleen Volume | The study was terminated early due to low enrollment. Analysis was not done. | Posted | Baseline, Week 24 |
|
| ||||||||||||||||||||
| Secondary | Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively, From Baseline in Total Symptom Score (MPN-SAF TSS) | The study was terminated early due to low enrollment. Analysis was not done. | Posted | Week 24 |
|
| ||||||||||||||||||||
| Secondary | Change From Baseline in MPN-SAF TSS Score | The study was terminated early due to low enrollment. Analysis was not done. | Posted | Baseline, Week 24 |
|
| ||||||||||||||||||||
| Secondary | Patient Global Impression of Change (PGIC) Score | The study was terminated early due to low enrollment. Analysis was not done. | Posted | Week 1, Week 24 |
|
| ||||||||||||||||||||
| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQol (EQ)-5D-5L Scores | The study was terminated early due to low enrollment. Analysis was not done. | Posted | Baseline, Day 1, Week 8, Week 12, Week 16, Week 24 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ruxolitinib | All participants received ruxolitinib. | 2 | 3 | 2 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| CYTOKINE RELEASE SYNDROME | Immune system disorders | MedDRA | Systematic Assessment |
| |
| LISTERIOSIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| ANAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| PORTAL VEIN THROMBOSIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| D006402 | Hematologic Diseases |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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