Trial · NCT01493414
INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
NCT01493414, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis. Trials, record NCT01493414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01493414
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
- NCT number
- NCT01493414
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,233 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Myelofibrosis
- Interventions
- INC424
- First posted
- 2011-12-16
- Last updated
- 2019-04-26
- Other registries' IDs
- eudract:2010-024473-39
- Results first posted
- 2019-04-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years | Baseline up to approximately 5 years | An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A non-serious AE is any AE that does not meet the criteria above. |
| Secondary | Percentage of Participants With at Least 50% Reduction in Spleen Length | Baseline up to approximately 5 years | Spleen length was assessed by manual palpation. Assessment of spleen response was repeated until early discontinuation of the study drug and also at study completion (28 days post end of treatment visit). |
| Secondary | Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length | Baseline up to approximately 5 years | Overall response is analyzed using the spleen response, as assessed by the investigator and also by deriving the response using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. Participants with spleen length at baseline between 5 and 10 cm were reported as Responders if reporting non palpable spleen; Stable disease does not meet criteria for response or disease progression and Progressive disease with an increase of 100% from baseline in spleen length. Participants with spleen length at baseline more than 10 cm were reported as Responders with spleen reduction of 50% from baseline; Stable disease does not meet criteria for response or disease progression and Progressive disease with an increase of 50% from baseline in spleen length. |
| Secondary | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Worst Post-baseline ECOG Status up to 5 Years | Baseline up to approximately 5 years | ECOG Performance Score has 5 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. 5 = Death. |
| Secondary | Change in Functional Assessment of Cancer Therapy (FACT-TOI, FACT-G) and FACT-Lymphoma (FACT-Lym) Total Scores Measured at Baseline and Week 48 | Baseline and Week 48 | The FACT-Lym questionnaire consists of a total of 42 questions divided between five subscales (i.e., physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma subscale). Each subscale questionnaire rates each question on a 5-point scale from 0 = Not at all to 4 = Very much. These scores were summed to three total sum scores, namely FACT-Lym score, FACT-Lym Trial Outcome Index (TOI), FACT-General (FACT-G) and FACT-Lym total score. Total scores: FACT-Lym=0-60, FACT-TOI=0-116, FACT-G total=0-108, FACT-Lym Total= 0-168. Higher scores are reflective of better HRQoL. |
| Secondary | Time to First Improvement in FACT-Lym, FACIT-Fatigue Score and ECOG Performance Status | Baseline up to approximately 5 years | Improvement was defined by the upper limit of the minimally important difference (MID). Patients with the best possible score at Baseline were excluded from this analysis because their HRQoL cannot be further improved. Responders and non-responders for each endpoint were defined based on change from baseline scores using pre specified cut-off points. Patients with an improved score compared to Baseline, for which the magnitude of the change was at least the cutoff value, were classified as responders; otherwise, as non-responders. The responder cutoff: ECOG cutoff=1, range=0 to 5, FACT-Lym cutoff=5.4, range 0-60, FACIT-Fatigue =5 and range=0-52.The median time to first improvement was estimated using the Kaplan Meier method and time to improvement event was determined based on upper bound of the MID. The time to improvement was calculated from the date of first study drug administration. |
| Secondary | Medical Resource Utilization up to 5 Years | Baseline up to approximately 5 years. | Percentage of patients requiring medical resources (blood transfusions, hospitalization, emergency room visits, general practitioners or specialists consultations, urgent care or splenic irradiation) up to 5 years. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years | Baseline up to approximately 5 years | Safety set includes all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With at Least 50% Reduction in Spleen Length | Baseline up to approximately 5 years | Full analysis set includes all patients who received at least one administration of study drug. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length | Baseline up to approximately 5 years | Full analysis set includes all patients who received at least one administration of study drug and were observed from baseline in to the study follow-up period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Worst Post-baseline ECOG Status up to 5 Years | Baseline up to approximately 5 years | Full analysis set includes all patients who received at least one administration of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Functional Assessment of Cancer Therapy (FACT-TOI, FACT-G) and FACT-Lymphoma (FACT-Lym) Total Scores Measured at Baseline and Week 48 | Baseline and Week 48 | Full analysis set includes all patients who received at least one administration of study drug. | scores on a scale | MEAN |
| SECONDARY | Time to First Improvement in FACT-Lym, FACIT-Fatigue Score and ECOG Performance Status | Baseline up to approximately 5 years | Full analysis set includes all patients who received at least one administration of study drug. | weeks | MEDIAN |
| SECONDARY | Medical Resource Utilization up to 5 Years | Baseline up to approximately 5 years. | Full analysis set includes all patients who received at least one administration of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years | INC424 | Adverse Events | 2153 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years | INC424 | Serious adverse events | 830 | Participants | |
| Percentage of Participants With at Least 50% Reduction in Spleen Length | INC424 | 71.7 | 95% Confidence Interval 69.7 to 73.7 | percentage of participants | |
| Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length | INC424 - Responders | Spleen length at baseline-Less than 5 cm | NA | Participants | |
| Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length | INC424 - Stable Disease | Spleen length at baseline-Less than 5 cm | NA | Participants | |
| Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length | INC424 - Progressive Disease | Spleen length at baseline-Less than 5 cm | NA | Participants | |
| Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length | INC424 - Missing | Spleen length at baseline-Less than 5 cm | NA | Participants | |
| Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length | INC424 - Responders | Spleen length at baseline-Between 5 and 10 cm | 421 | Participants | |
| Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length | INC424 - Stable Disease | Spleen length at baseline-Between 5 and 10 cm | 334 | Participants | |
| Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length | INC424 - Progressive Disease | Spleen length at baseline-Between 5 and 10 cm | 1 | Participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | INC424 | 2,233 | |
| Overall Study | COMPLETED | INC424 | 1,283 | |
| Overall Study | NOT COMPLETED | INC424 | 950 |
Source ClinicalTrials.gov
Adverse events589
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | INC424 | 1,300 | 2,233 | |
| other | Neutropenia | Blood and lymphatic system disorders | INC424 | 146 | 2,233 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | INC424 | 990 | 2,233 | |
| other | Abdominal pain | Gastrointestinal disorders | INC424 | 149 | 2,233 | |
| other | Constipation | Gastrointestinal disorders | INC424 | 121 | 2,233 | |
| other | Diarrhoea | Gastrointestinal disorders | INC424 | 267 | 2,233 | |
| other | Nausea | Gastrointestinal disorders | INC424 | 128 | 2,233 | |
| other | Asthenia | General disorders | INC424 | 331 | 2,233 | |
| other | Fatigue | General disorders | INC424 | 215 | 2,233 | |
| other | Oedema peripheral | General disorders | INC424 | 182 | 2,233 |
1 to 10 of 589Source ClinicalTrials.gov
See all 589 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | INC424 | 205 | 2,233 |
| Total, other adverse events | INC424 | 2,008 | 2,233 |
| Total, serious adverse events | INC424 | 830 | 2,233 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01493414
GET https://conductscience.org/api/trials/v1/NCT01493414/results?page=2