Trial · NCT00606307
Phase IIA Study of the HDAC Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases
NCT00606307, Phase 2, Completed, Italfarmaco; results first posted 2019-12-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase IIA Study of the HDAC Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases. Trials, record NCT00606307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00606307
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase IIA Study of the HDAC Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases
- NCT number
- NCT00606307
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Italfarmaco
- Conditions
- Myeloproliferative Diseases
- Interventions
- ITF2357
- First posted
- 2008-02-01
- Last updated
- 2019-12-03
- Results first posted
- 2019-12-03
- Limitations and caveats
- Non reported
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response | Every single week from week 1 to week 24 of treatment | Patients with Objective Response were defined as those patients achieving a complete, major, moderate or minor (only for Myelofibrosis patients) response during the experimental treatment course. The "best response" is reported hereunder by intensity of response. |
| Secondary | Change in JAK2 Mutated Allele Burden | At screening, at week 12, at week 24, at the end of treatment (EOT) visit | This outcome was assessed by quantitative real time Polymerase Chain Reaction (RT PCR). At each time point, the number of patients is the following: Screening: N=29 Week 12: N=20 Week 24: N=18 EOT: N=24. End of treatment corresponds to the last visit performed before treatment discontinuation. |
| Secondary | Number of Subject Experiencing an Adverse Event | At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at end of treatment visit | An adverse event (AE) is any untoward occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The adverse events must to be followed to the end of study (28 days after the last study drug intake). A serious AE (SAE) is defined as an untoward (unfavourable) medical occurrence that at any dose results in death, or is life-threatening or requires inpatient hospitalisation or prolongation of existing hospitalisation, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response | Every single week from week 1 to week 24 of treatment | ITT population: all recruited patients who received study medication and for whom at least one on-study tumour evaluation is available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in JAK2 Mutated Allele Burden | At screening, at week 12, at week 24, at the end of treatment (EOT) visit | Intent-to-treat population: all recruited patients who received study medication and for whom at least one on-study tumour evaluation is available. | percentage of change in allele burden | MEAN |
| SECONDARY | Number of Subject Experiencing an Adverse Event | At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at end of treatment visit | safety population: all recruited patients who received at least one dose of the study medication. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response | ITF2357 | complete responders | 2 | Participants | |
| Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response | ITF2357 | major responders | 12 | Participants | |
| Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response | ITF2357 | moderate responders | 2 | Participants | |
| Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response | ITF2357 | minor responders | 1 | Participants | |
| Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response | ITF2357 | non responders | 12 | Participants | |
| Change in JAK2 Mutated Allele Burden | ITF2357 | screening | 54.0 | Standard Deviation 19.7 | percentage of change in allele burden |
| Change in JAK2 Mutated Allele Burden | ITF2357 | week 12 | 49.4 | Standard Deviation 20.1 | percentage of change in allele burden |
| Change in JAK2 Mutated Allele Burden | ITF2357 | week 24 | 47.1 | Standard Deviation 20.0 | percentage of change in allele burden |
| Change in JAK2 Mutated Allele Burden | ITF2357 | EOT | 49.0 | Standard Deviation 21.5 | percentage of change in allele burden |
| Number of Subject Experiencing an Adverse Event | ITF2357 | number of patients with AE | 29 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ITF2357 | 29 | |
| Overall Study | COMPLETED | ITF2357 | 18 | |
| Overall Study | NOT COMPLETED | ITF2357 | 11 |
Source ClinicalTrials.gov
Adverse events71
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 | ITF2357 | 6 | 29 | 6 |
| other | Leukopenia | Blood and lymphatic system disorders | ITF2357 | 1 | 29 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | ITF2357 | 1 | 29 | 1 |
| other | Thrombocytopenia | Cardiac disorders | ITF2357 | 3 | 29 | 3 |
| other | Palpitation | Cardiac disorders | ITF2357 | 1 | 29 | 1 |
| other | Tachycardia | Cardiac disorders | ITF2357 | 1 | 29 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | ITF2357 | 6 | 29 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | ITF2357 | 3 | 29 | 3 |
| other | Constipation | Gastrointestinal disorders | ITF2357 | 1 | 29 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | ITF2357 | 18 | 29 | 18 |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ITF2357 | 0 | 29 |
| Total, other adverse events | ITF2357 | 29 | 29 |
| Total, serious adverse events | ITF2357 | 3 | 29 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00606307
GET https://conductscience.org/api/trials/v1/NCT00606307/events?page=2