Trial · NCT00726232
Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia
NCT00726232, Phase 2, Terminated, Incyte Corporation; results first posted 2012-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia. Trials, record NCT00726232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00726232
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia
- NCT number
- NCT00726232
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 73 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Myeloproliferative Neoplasm (MPN)
- Interventions
- Ruxolitinib
- First posted
- 2008-07-31
- Last updated
- 2025-10-29
- Other registries' IDs
- eudract:2008-001382-28
- Results first posted
- 2012-02-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3 | For a confirmed response all criteria must have been sustained for at least 2 months. CR: * Hematocrit \< 45% in men and \< 42% in women * No phlebotomy for 1 month * No palpable splenomegaly * White blood cells \< 10 x 10\^9/L with normal differential and platelets \< 400 x 10\^9/L * No sustained leucopenia or thrombocytopenia (\>2 weeks) * No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss) PR: * Hematocrit \< 45% in men and \< 42% in women * 50% reduction in phlebotomy requirements from 6 months before treatment started * 50% reduction in palpable splenomegaly |
| Primary | Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3. | For a confirmed response all criteria must have been sustained for at least 2 months. Complete Clinical Response: * Platelet count \< 400 x 10\^9/L * White blood cell count \< 10 x 10\^9/L with normal differential and Hematocrit ≤ upper limit of normal * Absence of sustained (\> 2 weeks) anemia or leucopenia based on institutional normal ranges * Absence of systemic ET symptoms (pruritus, bone pain, weakness, night sweats, paresthesias) * Absence of palpable splenomegaly Partial Clinical Response: * Platelet count \< 400 x 10\^9/L * 50% reduction in palpable splenomegaly |
| Secondary | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | Baseline and Week 12 (Cycle 4, Day 1) | The individual components of clinical response included: * Hematocrit (Hct) \< 45% without phlebotomy * Absence of palpable splenomegaly * 50% reduction in spleen size * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L |
| Secondary | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks | Baseline and Week 24 (Cycle 7, Day 1) | The individual components of clinical response included: * Hematocrit (Hct) \< 45% without phlebotomy * Absence of palpable splenomegaly * 50% reduction in spleen size * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L |
| Secondary | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks | Baseline and Week 36 (Cycle 10, Day 1) | The individual components of clinical response included: * Hematocrit (Hct) \< 45% without phlebotomy * Absence of palpable splenomegaly * 50% reduction in spleen size * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L |
| Secondary | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks | Baseline and 4 weeks (Cycle 2, Day 1) | The individual components of clinical response included: * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L * 50% reduction in spleen size * Absence of palpable splenomegaly |
| Secondary | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks | Baseline and 24 weeks (Cycle 7, Day 1) | The individual components of clinical response included: * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L * 50% reduction in spleen size * Absence of palpable splenomegaly |
| Secondary | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks | Baseline and 36 weeks (Cycle 10, Day 1) | The individual components of clinical response included: * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L * 50% reduction in spleen size * Absence of palpable splenomegaly |
| Secondary | Change From Baseline to Week 4 in Polycythemia Vera Symptoms | Baseline and Week 4 (Cycle 2, Day 1) | Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms. For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats. |
| Secondary | Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms | Baseline and Week 4 (Cycle 2, Day 1) | Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms. For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3 | Polycythemia Vera intent to treat population, including all patients who took at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | Baseline and Week 12 (Cycle 4, Day 1) | Polycythemia Vera intent to treat population for whom data was available. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3. | Essential thrombocythemia intent to treat population, including all patients who took at least 1 dose of study drug. One patient in the 50 mg QD group did not have a response assessment at Cycle 3, Day 1. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks | Baseline and Week 24 (Cycle 7, Day 1) | Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks | Baseline and Week 36 (Cycle 10, Day 1) | Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks | Baseline and 4 weeks (Cycle 2, Day 1) | Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks | Baseline and 24 weeks (Cycle 7, Day 1) | Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks | Baseline and 36 weeks (Cycle 10, Day 1) | Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 4 in Polycythemia Vera Symptoms | Baseline and Week 4 (Cycle 2, Day 1) | Polycythemia Vera intent to treat population who had symptom scores \> 0 at baseline for whom data was available. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms | Baseline and Week 4 (Cycle 2, Day 1) | Essential Thrombocythemia intent to treat population who had symptom scores \> 0 at baseline and for whom data was available. | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group118
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | PV: Ruxolitinib 10 mg BID | 58 | percentage of participants | ||
| Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | PV: Ruxolitinib 25 mg BID | 50 | percentage of participants | ||
| Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | PV: Ruxolitinib 50 mg QD | 57 | percentage of participants | ||
| Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | PV: Ruxolitinib 10 mg BID | Hematocrit <45% Without Phlebotomy | 95 | percentage of participants | |
| Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | PV: Ruxolitinib 25 mg BID | Hematocrit <45% Without Phlebotomy | 88 | percentage of participants | |
| Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | PV: Ruxolitinib 50 mg QD | Hematocrit <45% Without Phlebotomy | 86 | percentage of participants | |
| Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | PV: Ruxolitinib 10 mg BID | Absence of palpable splenomegaly | 68 | percentage of participants | |
| Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | PV: Ruxolitinib 25 mg BID | Absence of palpable splenomegaly | 50 | percentage of participants | |
| Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | PV: Ruxolitinib 50 mg QD | Absence of palpable splenomegaly | 57 | percentage of participants | |
| Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | PV: Ruxolitinib 10 mg BID | 50% reduction in spleen size | 74 | percentage of participants |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow80
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Phase (Dose-finding) | STARTED | Polycythemia Vera (PV): Ruxolitinib 10 mg BID | 19 | |
| Initial Phase (Dose-finding) | STARTED | PV: Ruxolitinib 25 mg BID | 8 | |
| Initial Phase (Dose-finding) | STARTED | PV: Ruxolitinib 50 mg QD | 7 | |
| Initial Phase (Dose-finding) | STARTED | Essential Thrombocythemia (ET): Ruxolitinib 10 mg BID | 8 | |
| Initial Phase (Dose-finding) | STARTED | ET: Ruxolitinib 25 mg BID | 22 | |
| Initial Phase (Dose-finding) | STARTED | ET: Ruxolitinib 50 mg QD | 9 | |
| Initial Phase (Dose-finding) | STARTED | PV: Ruxolitinib All Doses Combined- Expansion Phase | 0 | |
| Initial Phase (Dose-finding) | STARTED | ET: Ruxolitinib All Doses Combined-expansion Phase | 0 | |
| Initial Phase (Dose-finding) | Safety Evaluable Participants | Polycythemia Vera (PV): Ruxolitinib 10 mg BID | 19 | |
| Initial Phase (Dose-finding) | Safety Evaluable Participants | PV: Ruxolitinib 25 mg BID | 8 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 participant flowAdverse events1,896
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 | PV: Ruxolitinib 10 mg BID | 16 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | PV: Ruxolitinib 25 mg BID | 6 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | PV: Ruxolitinib 50 mg QD | 3 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | ET: Ruxolitinib 10 mg BID | 5 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | ET: Ruxolitinib 25 mg BID | 19 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | ET: Ruxolitinib 50 mg QD | 6 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | PV: Ruxolitinib All Doses Combined- Expansion Phase | 27 | 34 | |
| other | Anaemia | Blood and lymphatic system disorders | ET: Ruxolitinib All Doses Combined-expansion Phase | 32 | 39 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PV: Ruxolitinib 10 mg BID | 6 | 19 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PV: Ruxolitinib 25 mg BID | 4 | 8 |
1 to 10 of 1,896Source ClinicalTrials.gov
See all 1,896 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PV: Ruxolitinib 10 mg BID | ||
| Total, all-cause mortality | PV: Ruxolitinib 25 mg BID | ||
| Total, all-cause mortality | PV: Ruxolitinib 50 mg QD | ||
| Total, all-cause mortality | ET: Ruxolitinib 10 mg BID | ||
| Total, all-cause mortality | ET: Ruxolitinib 25 mg BID | ||
| Total, all-cause mortality | ET: Ruxolitinib 50 mg QD | ||
| Total, all-cause mortality | PV: Ruxolitinib All Doses Combined- Expansion Phase | ||
| Total, all-cause mortality | ET: Ruxolitinib All Doses Combined-expansion Phase | ||
| Total, other adverse events | PV: Ruxolitinib 10 mg BID | 19 | 19 |
| Total, other adverse events | PV: Ruxolitinib 25 mg BID | 8 | 8 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25999444 | DERIVED |
Source PubMed
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/NCT00726232
GET https://conductscience.org/api/trials/v1/NCT00726232/results?page=2