Trial · NCT00928707
Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera
NCT00928707, Phase 2, Completed, Italfarmaco; results first posted 2019-10-31
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera. Trials, record NCT00928707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00928707
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera
- NCT number
- NCT00928707
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Italfarmaco
- Conditions
- Polycythemia Vera
- Interventions
- GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea, GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea
- First posted
- 2009-06-26
- Last updated
- 2019-10-31
- Results first posted
- 2019-10-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Overall Haematological Response at Week 12. | At week 12 of treatment | The percentage of patients with overall (complete or partial) response at week 12 were assessed. · Complete response: 1. HCT (Hematocrit) \< 45% without phlebotomy, and 2. platelets ≤ 400 x109/L, and 3. WBC (white blood cell) ≤ 10 x 109/L, and 4. no splenomegaly, and 5. no disease related systemic symptoms (microvascular disturbances, pruritus, headache); · Partial response: 1. HCT \< 45% without phlebotomy, or 2. fulfilment of at least 3 of the other above mentioned criteria; · No response: any response that did not satisfy the criteria set for partial response. |
| Secondary | Percentage of Patients With Overall Haematological Response at Week 24 by Dose Escalation After Week 12. | At week 24 of treatment | Haematological response after a 50 mg increase of the initial Givinostat dose in non-responder patients at the time when the primary endpoint was assessed (week 12). * Complete response: 1. HCT\< 45% without phlebotomy, and 2. platelets ≤ 400 x109/L, and 3. WBC ≤ 10 x 109/L, and 4. no splenomegaly, and 5. no disease related systemic symptoms (microvascular disturbances, pruritus, headache); * Partial response: 1. HCT \< 45% without phlebotomy, or 2. fulfilment of at least 3 of the other above mentioned criteria; * No response: any response that did not satisfy the criteria set for partial response. |
| Secondary | Change From Baseline of the JAK2V617F Allele Burden by Quantitative RT-PCR | At weeks 12, 24, at "drop out visit" and at "End of Study" (EOS). EOS stays for 7 days after last drug intake if patient is withdrawn from the study before week 24. | To determine JAK2V617F mutational status, a quantitative RT-PCR (Real Time-Polymerase Chain Reaction) is executed on peripheral blood granulocyte and haematopoietic colonies (with and without hepatocyte growth factors - HGFs). |
| Secondary | Percentage of Patients With a Reduction of the Fraction of JAK2V617F Positive Clonogenic Progenitor by Timepoints | Baseline, at weeks 12 and 24 | JAK2V617F genotyping and quantification were performed on gradient-separated mononuclear cells during the pre-treatment evaluations (baseline), halfway through the study (12th weeks) and at the end of the study period (24th weeks). Baseline: n=22 (50 mg od); 22 (50 mg bid) Week 12: n=20 (50 mg od); 19 (50 mg bid) Week 24: n=18 (50 mg od); 18 (50 mg bid) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Overall Haematological Response at Week 12. | At week 12 of treatment | Safety/ITT population: included all randomized subjects who received at least one dose of study medication. | percentage of particpants | NUMBER |
| SECONDARY | Percentage of Patients With Overall Haematological Response at Week 24 by Dose Escalation After Week 12. | At week 24 of treatment | Safety/Intention to treat (ITT) population included all randomized subjects who received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline of the JAK2V617F Allele Burden by Quantitative RT-PCR | At weeks 12, 24, at drop out visit and at End of Study (EOS). EOS stays for 7 days after last drug intake if patient is withdrawn from the study before week 24. | Safety/Intention-to-treat (ITT) population, which included all randomized subjects who received at least one dose of study medication. | percent change | MEAN |
| SECONDARY | Percentage of Patients With a Reduction of the Fraction of JAK2V617F Positive Clonogenic Progenitor by Timepoints | Baseline, at weeks 12 and 24 | Safety/Intention-to-treat (ITT) population, which included all randomized subjects who received at least one dose of study medication. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Overall Haematological Response at Week 12. | GIVINOSTAT + MTD Hydroxyurea_1 | Responder | 54.5 | 95% Confidence Interval 33.7 to 75.4 | percentage of particpants |
| Percentage of Patients With Overall Haematological Response at Week 12. | GIVINOSTAT + MTD Hydroxyurea_2 | Responder | 50.0 | 95% Confidence Interval 29.1 to 70.9 | percentage of particpants |
| Percentage of Patients With Overall Haematological Response at Week 12. | GIVINOSTAT + MTD Hydroxyurea_1 | Non responder | 45.5 | 95% Confidence Interval 24.6 to 66.3 | percentage of particpants |
| Percentage of Patients With Overall Haematological Response at Week 12. | GIVINOSTAT + MTD Hydroxyurea_2 | Non responder | 50.0 | 95% Confidence Interval 29.1 to 70.9 | percentage of particpants |
| Percentage of Patients With Overall Haematological Response at Week 24 by Dose Escalation After Week 12. | GIVINOSTAT + MTD Hydroxyurea_1 | Responder | 63.6 | 95% Confidence Interval 43.5 to 83.7 | percentage of participants |
| Percentage of Patients With Overall Haematological Response at Week 24 by Dose Escalation After Week 12. | GIVINOSTAT + MTD Hydroxyurea_2 | Responder | 40.9 | 95% Confidence Interval 20.4 to 61.5 | percentage of participants |
| Percentage of Patients With Overall Haematological Response at Week 24 by Dose Escalation After Week 12. | GIVINOSTAT + MTD Hydroxyurea_1 | Non responder | 36.4 | 95% Confidence Interval 16.3 to 56.5 | percentage of participants |
| Percentage of Patients With Overall Haematological Response at Week 24 by Dose Escalation After Week 12. | GIVINOSTAT + MTD Hydroxyurea_2 | Non responder | 59.1 | 95% Confidence Interval 38.5 to 79.6 | percentage of participants |
| Change From Baseline of the JAK2V617F Allele Burden by Quantitative RT-PCR | GIVINOSTAT + MTD Hydroxyurea_1 | Week 12 | -2.6 | Standard Deviation 8.2 | percent change |
| Change From Baseline of the JAK2V617F Allele Burden by Quantitative RT-PCR | GIVINOSTAT + MTD Hydroxyurea_2 | Week 12 | 0.00 | Standard Deviation 6.0 | percent change |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GIVINOSTAT +Maximum Tolerated Dose (MTD) of Hydroxyurea (HU)_1 | 23 | |
| Overall Study | STARTED | GIVINOSTAT +Maximum Tolerated Dose (MTD) of Hydroxyurea (HU)_2 | 22 | |
| Overall Study | COMPLETED | GIVINOSTAT +Maximum Tolerated Dose (MTD) of Hydroxyurea (HU)_1 | 22 | |
| Overall Study | COMPLETED | GIVINOSTAT +Maximum Tolerated Dose (MTD) of Hydroxyurea (HU)_2 | 22 | |
| Overall Study | NOT COMPLETED | GIVINOSTAT +Maximum Tolerated Dose (MTD) of Hydroxyurea (HU)_1 | 1 | |
| Overall Study | NOT COMPLETED | GIVINOSTAT +Maximum Tolerated Dose (MTD) of Hydroxyurea (HU)_2 | 0 |
Source ClinicalTrials.gov
Adverse events142
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 | Haematoma | Vascular disorders | GIVINOSTAT + MTD Hydroxyurea_1 | 1 | 22 | 1 |
| other | Haematoma | Vascular disorders | GIVINOSTAT + MTD Hydroxyurea_2 | 0 | 22 | 0 |
| other | Hypertension | Vascular disorders | GIVINOSTAT + MTD Hydroxyurea_1 | 0 | 22 | 0 |
| other | Hypertension | Vascular disorders | GIVINOSTAT + MTD Hydroxyurea_2 | 2 | 22 | 2 |
| other | Phlebitis | Vascular disorders | GIVINOSTAT + MTD Hydroxyurea_1 | 0 | 22 | 0 |
| other | Phlebitis | Vascular disorders | GIVINOSTAT + MTD Hydroxyurea_2 | 1 | 22 | 1 |
| other | Thrombophlebitis superficial | Vascular disorders | GIVINOSTAT + MTD Hydroxyurea_1 | 1 | 22 | 2 |
| other | Thrombophlebitis superficial | Vascular disorders | GIVINOSTAT + MTD Hydroxyurea_2 | 0 | 22 | 0 |
| other | Curetting of chalazion | Surgical and medical procedures | GIVINOSTAT + MTD Hydroxyurea_1 | 1 | 22 | 1 |
| other | Curetting of chalazion | Surgical and medical procedures | GIVINOSTAT + MTD Hydroxyurea_2 | 0 | 22 | 0 |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GIVINOSTAT + MTD Hydroxyurea_1 | 0 | 22 |
| Total, all-cause mortality | GIVINOSTAT + MTD Hydroxyurea_2 | 0 | 22 |
| Total, other adverse events | GIVINOSTAT + MTD Hydroxyurea_1 | 21 | 22 |
| Total, other adverse events | GIVINOSTAT + MTD Hydroxyurea_2 | 21 | 22 |
| Total, serious adverse events | GIVINOSTAT + MTD Hydroxyurea_1 | 2 | 22 |
| Total, serious adverse events | GIVINOSTAT + MTD Hydroxyurea_2 | 1 | 22 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GIVINOSTAT + MTD Hydroxyurea_1 vs GIVINOSTAT + MTD Hydroxyurea_2: deaths from any cause | Trial comparisons |
| GIVINOSTAT + MTD Hydroxyurea_1 vs GIVINOSTAT + MTD Hydroxyurea_2: serious adverse events | Trial comparisons |
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/NCT00928707
GET https://conductscience.org/api/trials/v1/NCT00928707/results?page=2