Description:
This is a two-part, multicenter, open label, non-randomized, phase Ib/II study to assess the
safety and tolerability, Maximum Tolerated Dose and preliminary efficacy of Givinostat in
patients with JAK2V617F positive Polycythemia Vera. Part A is the dose finding part while
Part B is assessing the preliminary efficacy. Patients will be enrolled either in Part A or
Part B and transition from one part to the other is not allowed.
Eligible patients for this study will have a confirmed diagnosis of Polycythemia Vera
according to the revised World Health Organization criteria. Only if the enrolment in Part A
is slow (i.e. < 5 patients enrolled in 3 months), eligibility for this part of the study may
be expanded to all patients with chronic myeloproliferative neoplasms.
Study therapy will be administered in 28 day cycles (4 weeks of treatment). Disease response
will be evaluated according to the European LeukemiaNet criteria after 3 and 6 cycles (i.e.
at weeks 12 and 24, respectively) of treatment with Givinostat for both parts of the study.
All phlebotomies performed in the first 3 weeks of treatment will not be counted to assess
the clinico-haematological response.
The study will last up to a maximum of 24 weeks of treatment. However, after completion of
the trial, all patients achieving clinical benefit will be allowed to continue treatment with
Givinostat (at the same dose and schedule) in a long-term study.
Safety will be monitored at each visit throughout the entire duration of the study. Treatment
will be administered on an outpatient basis and patients will be followed regularly with
physical and laboratory tests, as specified in the protocol; in case of hospitalization, the
treatment will be continued or interrupted according to the Investigators' decision.
Title
- Brief Title: A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera
- Official Title: A Two-part Study Top Assess the Safety and Preliminary Efficacy of Givinostat in Patients With JAK2V617F Positive Polycythemia Vera
Clinical Trial IDs
- ORG STUDY ID:
DSC/12/2357/45
- SECONDARY ID:
2013-000860-27
- NCT ID:
NCT01901432
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Givinostat | Givinostat (ITF2357) | Givinostat |
Purpose
This is a two-part, multicenter, open label, non-randomized, phase Ib/II study to assess the
safety and tolerability, Maximum Tolerated Dose and preliminary efficacy of Givinostat in
patients with JAK2V617F positive Polycythemia Vera. Part A is the dose finding part while
Part B is assessing the preliminary efficacy. Patients will be enrolled either in Part A or
Part B and transition from one part to the other is not allowed.
Eligible patients for this study will have a confirmed diagnosis of Polycythemia Vera
according to the revised World Health Organization criteria. Only if the enrolment in Part A
is slow (i.e. < 5 patients enrolled in 3 months), eligibility for this part of the study may
be expanded to all patients with chronic myeloproliferative neoplasms.
Study therapy will be administered in 28 day cycles (4 weeks of treatment). Disease response
will be evaluated according to the European LeukemiaNet criteria after 3 and 6 cycles (i.e.
at weeks 12 and 24, respectively) of treatment with Givinostat for both parts of the study.
All phlebotomies performed in the first 3 weeks of treatment will not be counted to assess
the clinico-haematological response.
The study will last up to a maximum of 24 weeks of treatment. However, after completion of
the trial, all patients achieving clinical benefit will be allowed to continue treatment with
Givinostat (at the same dose and schedule) in a long-term study.
Safety will be monitored at each visit throughout the entire duration of the study. Treatment
will be administered on an outpatient basis and patients will be followed regularly with
physical and laboratory tests, as specified in the protocol; in case of hospitalization, the
treatment will be continued or interrupted according to the Investigators' decision.
Detailed Description
This is a two-part, multicenter, open label, non-randomized, phase Ib/II study to assess the
safety and tolerability, MTD and preliminary efficacy of Givinostat in patients with
JAK2V617F positive PV.
Part A is the dose escalation portion of the study and, once the MTD has been established,
Part B will commence where the preliminary efficacy of Givinostat in PV patients will be
established. Patients will be enrolled either in Part A or Part B and transition from one
part to the other is not allowed. Only PV patients from Part A assigned to the dose selected
for Part B (MTD) may be counted towards the efficacy assessment in Part B.
Eligible patients for this study will have a confirmed diagnosis of PV according to the
revised WHO criteria and the JAK2V617F positivity. Only if the enrolment in Part A is slow
(i.e. < 5 patients enrolled in 3 months), eligibility for this part of the study may be
expanded to all patients with cMPN.
After providing informed written consent before undertaking any protocol-related procedure, a
unique patient identification code (i.e. patient screening ID which will be a combination of
his/her site ID, study part ID and patient screening number, e.g. IT01-A01) will be assigned
to each patient and it will identify the patient within his/her enrolment confirmation by
Italfarmaco S.p.A. or its designee and never be reused in case of screening failure. After
the enrolment confirmation and the assignation of the dose level before the first drug
intake, a unique patient identification code (i.e. patient ID which will be a combination of
patient screening number ID and dose level ID, e.g. IT01-A01-DL1) will be assigned to each
patient and it will identify the patient throughout his/her participation in the study and
never be reused in case of premature drop-out.
Study therapy will be administered in 28 day cycles. In fact, the "cycle" is defined as 4
weeks of treatment.
Disease response will be evaluated according to the clinico-haematological ELN criteria after
3 and 6 cycles (i.e. at weeks 12 and 24, respectively) of treatment with Givinostat for both
parts of the study. All phlebotomies performed in the first 3 weeks of treatment will not be
counted to assess the clinico-haematological response.
The study will last up to a maximum of 24 weeks of treatment. However, after completion of
the trial, all patients achieving clinical benefit will be allowed to continue treatment with
Givinostat (at the same dose and schedule) in a long-term study (Study N.: DSC/11/2357/44).
Safety will be monitored at each visit throughout the entire duration of the study. Treatment
will be administered on an outpatient basis and patients will be followed regularly with
physical and laboratory tests, as specified in the protocol; in case of hospitalization, the
treatment will be continued or interrupted according to the Investigators' decision.
Trial Arms
Name | Type | Description | Interventions |
---|
Givinostat | Experimental | In Part A patients will treated in dose levels at the following daily doses of Givinostat:
50 mg b.i.d.,
100 mg b.i.d.;
150 mg b.i.d.,
200 mg b.i.d.;
150 mg t.i.d.;
200 mg t.i.d.. Intermediate dose levels and, consequently, additionally dose levels may be used to establish the Maximum Tolerated Dose.
In Part B patients will be treated at the Maximum Tolerated Dose established in Part A.
The product will be supplied as hard gelatine capsules for oral administration at the strength of 50 mg, 75 mg and/or 100 mg each. | |
Eligibility Criteria
Inclusion Criteria:
1. Patients must be able to provide informed consent and be willing to sign an informed
consent form;
2. Patients must have an age ≥18 years;
3. Patients must have a confirmed diagnosis of Polycythemia Vera according to the revised
World Health Organization criteria;
4. Patients must have mutated Janus Kinase 2 (mutation V617F) positive disease;
5. Patients must have an active/not controlled disease defined as
1. hematocrit ≥ 45% or hematocrit <45% in need of phlebotomy, and
2. platelet count > 400 x109/L, and
3. white blood cell count > 10 x109/L;
6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
in Part A, ECOG performance status ≤ 2 in Part B within 7 days of initiating study
drug;
7. Female patient of childbearing potential has a negative serum or urine pregnancy test
within 72 hours of the first dose of study therapy;
8. Use of an effective means of contraception for women of childbearing potential and men
with partners of childbearing potential;
9. Adequate and acceptable organ function within 7 days of initiating study drug;
10. Willingness and capability to comply with the requirements of the study.
Note that if the enrolment in Part A is slow (i.e. < 5 patients enrolled in 3 months),
eligibility for this part of the study may be expanded to all patients with chronic
myeloproliferative neoplasms. In this case, the inclusion criteria 5 will be modified as
following only for Part A:
5. Patients must have an active/not controlled disease defined as:
1. Essential Thrombocythemia patients: Platelet count > 600 x109/L;
2. Myelofibrosis patients: no response according to European Myelofibrosis Network
criteria.
Exclusion Criteria:
1. Active bacterial or mycotic infection requiring antimicrobial treatment;
2. Pregnancy or nursing;
3. A clinically significant corrected QT interval prolongation at baseline;
4. Use of concomitant medications known to prolong the corrected QT interval;
5. Clinically significant cardiovascular disease including:
1. Uncontrolled hypertension despite medical treatment, myocardial infarction,
unstable angina within 6 months from study start;
2. New York Heart Association Grade II or greater congestive heart failure;
3. History of any cardiac arrhythmia requiring medication (irrespective of its
severity);
4. A history of additional risk factors for torsade de pointes;
6. Known positivity for human immunodeficiency;
7. Known active hepatitis B virus and/or hepatitis C virus infection;
8. Platelet count < 100 x109/L within 14 days before enrolment;
9. Absolute neutrophil count < 1.2x109/L within 14 days before enrolment;
10. Serum creatinine > 2 times the upper limit of normal;
11. Total serum bilirubin > 1.5 times the upper limit of normal except in case of
Gilbert's disease;
12. Serum aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 3 times the
upper limit of normal;
13. History of other diseases (including active tumours), metabolic dysfunctions, physical
examination findings, or clinical laboratory findings giving reasonable suspicion of a
disease or condition that contraindicates use of an investigational drug or that might
affect interpretation of the results of the study or render the subject at high risk
from treatment complications;
14. Prior treatment with a Janus Kinase 2 or Histone Deacetylase inhibitor or
participation in an interventional clinical trial for chronic myeloproliferative
neoplasms;
15. Systemic treatment for chronic myeloproliferative neoplasms other than aspirin/cardio
aspirin;
16. Hydroxyurea within 28 days before enrolment;
17. Interferon alpha within 14 days before enrolment;
18. Anagrelide within 7 days before enrolment;
19. Any other investigational drug or device within 28 days before enrolment;
20. Patient with known hypersensitivity to the components of study therapy.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in Part A of the Study |
Time Frame: | 168 days (up to Cycle 6 Day 28 in Part A). |
Safety Issue: | |
Description: | Evaluations were performed on the type, incidence and severity of TEAEs, graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.03, following administration of givinostat for up to 6 cycles of treatment in Part A. Grades 1 through 5 were as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening or requiring hospitalisation; Grade 4: Life threatening consequences; Grade 5: Death related to AE. Results are reported as number of patients with TEAEs for each of the indicated categories. Definitions: drug-related TEAE / treatment-emergent serious adverse event (TESAE) corresponded to reasonable suspicion that the TEAE / TESAE was associated with the use of the study drug, according to investigator assessment; discontinuation refers to discontinuation from treatment. |
Secondary Outcome Measures
Measure: | ORR After 3 Cycles and After 6 Cycles in Part A of the Study |
Time Frame: | 84 and 168 days (up to Cycle 3 Day 28 and Cycle 6 Day 28 in Part A). |
Safety Issue: | |
Description: | ORR following administration of givinostat after 3 cycles and after 6 cycles in Part A, reported as percentage of patients with a response. Response was evaluated according to the clinico-hematological ELN response criteria. If Investigator's clinical response assessment (taking into account the overall medical judgment of the specific patient's case) was not in agreement with exact application of the ELN response criteria, the Investigator's assessment superseded the mathematical application of these criteria and was used for analysis. Analysis performed using the dataset for all Part A patients combined. |
Measure: | ORR After 6 Cycles in Part B of the Study |
Time Frame: | 168 days (up to Cycle 6 Day 28 in Part B). |
Safety Issue: | |
Description: | ORR following administration of givinostat at the MTD for 6 cycles in Part B, reported as percentage of patients with a response. Response was evaluated according to the clinico-hematological ELN response criteria. If Investigator's clinical response assessment (taking into account the overall medical judgment of the specific patient's case) was not in agreement with exact application of the ELN response criteria, the Investigator's assessment superseded the mathematical application of these criteria and was used for analysis. |
Measure: | Number of Patients Experiencing TEAEs After 6 Cycles in Part B of the Study |
Time Frame: | 168 days (up to Cycle 6 Day 28 in Part B). |
Safety Issue: | |
Description: | Evaluations were performed on the type, incidence and severity of TEAEs, graded according to CTCAE v. 4.03, following administration of givinostat at the MTD for up to 6 cycles of treatment in Part B. Grades 1 through 5 were as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening or requiring hospitalisation; Grade 4: Life threatening consequences; Grade 5: Death related to AE. Results are reported as number of patients with TEAEs for each of the indicated categories. Definitions: drug-related TEAE / TESAE corresponded to reasonable suspicion that the TEAE / TESAE was associated with the use of the study drug, according to investigator assessment; discontinuation refers to discontinuation from treatment. Results are reported as number of patients with TEAEs for each of the indicated categories. |
Measure: | Assessment of Maximum Plasma Concentration (Cmax) of Givinostat and Metabolites (ITF2374 and ITF2375) in Part A of the Study |
Time Frame: | Blood samples were collected in Part A on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 1 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose. |
Safety Issue: | |
Description: | Pharmacokinetic (PK) evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Cmax following administration of givinostat for 1 cycle in Part A. PK calculations were performed by standard non-compartmental analysis. Results are reported for Cycle 1 Day 1 and Cycle 1 Day 28.
Note: concentration data for ITF2374 (Cycle 1 Day 1 and Cycle 1 Day 28) and for ITF2375 (Cycle 1 Day 1) in the DL0 dose group of Part A were not available for PK analysis. |
Measure: | Assessment of Time to Maximum Plasma Concentration (Tmax) of Givinostat and Metabolites (ITF2374 and ITF2375) in Part A of the Study |
Time Frame: | Blood samples were collected in Part A on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 1 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose. |
Safety Issue: | |
Description: | PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Tmax following administration of givinostat for 1 cycle in Part A. PK calculations were performed by standard non-compartmental analysis. Results are reported for Cycle 1 Day 1 and Cycle 1 Day 28.
Note: concentration data for ITF2374 (Cycle 1 Day 1 and Cycle 1 Day 28) and for ITF2375 (Cycle 1 Day 1) in the DL0 dose group of Part A were not available for PK analysis. |
Measure: | Assessment of Time of the Last Detectable Concentration (Tlast) of Givinostat and Metabolites (ITF2374 and ITF2375) in Part A of the Study |
Time Frame: | Blood samples were collected in Part A on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 1 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose. |
Safety Issue: | |
Description: | PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Tlast following administration of givinostat for 1 cycle in Part A. PK calculations were performed by standard non-compartmental analysis. Results are reported for Cycle 1 Day 1 and Cycle 1 Day 28.
Note: concentration data for ITF2374 (Cycle 1 Day 1 and Cycle 1 Day 28) and for ITF2375 (Cycle 1 Day 1) in the DL0 dose group of Part A were not available for PK analysis. |
Measure: | Assessment of Area Under Plasma Concentration Versus the Time Curve up to the Last Detectable Concentration (AUClast) of Givinostat and Metabolites (ITF2374 and ITF2375) in Part A of the Study |
Time Frame: | Blood samples were collected in Part A on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 1 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose. |
Safety Issue: | |
Description: | PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of AUClast following administration of givinostat for 1 cycle in Part A. PK calculations were performed by standard non-compartmental analysis and AUClast was calculated using the linear trapezoidal rule. Results are reported for Cycle 1 Day 1 and Cycle 1 Day 28.
Note: concentration data for ITF2374 (Cycle 1 Day 1 and Cycle 1 Day 28) and for ITF2375 (Cycle 1 Day 1) in the DL0 dose group of Part A were not available for PK analysis. |
Measure: | Assessment of Area Under Plasma Concentration Versus the Time Curve in the Dosing Interval (0-12 Hours) (AUC0-12) of Givinostat and Metabolites (ITF2374 and ITF2375) in Part A of the Study |
Time Frame: | Blood samples were collected in Part A on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 1 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose. |
Safety Issue: | |
Description: | PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of AUC0-12 following administration of givinostat for 1 cycle in Part A. PK calculations were performed by standard non-compartmental analysis and AUC0-12 was calculated using the linear trapezoidal rule. Results are reported for Cycle 1 Day 1 and Cycle 1 Day 28.
Note:concentration data for ITF2374 (Cycle 1 Day 1 and Cycle 1 Day 28) across all dose groups and for ITF2375 (Cycle 1 Day 1) in the DL0 dose group of Part A were not available for PK analysis. |
Measure: | Assessment of Cmax of Givinostat and Metabolites (ITF2374 and ITF2375) in Part B of the Study |
Time Frame: | Blood samples were collected in Part B on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 2 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose. |
Safety Issue: | |
Description: | PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Cmax following administration of givinostat for 2 cycles in Part B. PK calculations were performed by standard non-compartmental analysis. Following definition of the MTD in Part A, during Part B Cycle 1, givinostat was administered at 100 mg b.i.d. and during Part B Cycle 2 was administered at 100 mg, 75 mg and 50 mg b.i.d. (since dose reductions due to TEAEs were allowed from Cycle 2 onwards, as per protocol). Results are reported for Cycle 1 Day 1 and Cycle 2 Day 28 for the doses administered during Part B.
Note: PK evaluation for the givinostat 75 mg and 50 mg b.i.d. dose groups for Cycle 1 Day 1 was not applicable (since all received givinostat 100 mg b.i.d.). Additionally, concentration data for ITF2375 (Cycle 1 Day 28) in the 50 mg b.i.d. dose group was not available for PK analysis. |
Measure: | Assessment of Tmax of Givinostat and Metabolites (ITF2374 and ITF2375) in Part B of the Study |
Time Frame: | Blood samples were collected in Part B on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 2 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose. |
Safety Issue: | |
Description: | PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Tmax following administration of givinostat for 2 cycles in Part B. PK calculations were performed by standard non-compartmental analysis. Following definition of the MTD in Part A, during Part B Cycle 1, givinostat was administered at 100 mg b.i.d. and during Part B Cycle 2 was administered at 100 mg, 75 mg and 50 mg b.i.d. (since dose reductions due to TEAEs were allowed from Cycle 2 onwards, as per protocol). Results are reported for Cycle 1 Day 1 and Cycle 2 Day 28 for the doses administered during Part B.
Note: PK evaluation for the givinostat 75 mg and 50 mg b.i.d. dose groups for Cycle 1 Day 1 was not applicable (since all received givinostat 100 mg b.i.d.). Additionally, concentration data for ITF2375 (Cycle 1 Day 28) in the 50 mg b.i.d. dose group was not available for PK analysis. |
Measure: | Assessment of Tlast of Givinostat and Metabolites (ITF2374 and ITF2375) in Part B of the Study |
Time Frame: | Blood samples were collected in Part B on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 2 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose. |
Safety Issue: | |
Description: | PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Tlast following administration of givinostat for 2 cycles in Part B. PK calculations were performed by standard non-compartmental analysis. Following definition of the MTD in Part A, during Part B Cycle 1, givinostat was administered at 100 mg b.i.d. and during Part B Cycle 2 was administered at 100 mg, 75 mg and 50 mg b.i.d. (since dose reductions due to TEAEs were allowed from Cycle 2 onwards, as per protocol). Results are reported for Cycle 1 Day 1 and Cycle 2 Day 28 for the doses administered during Part B.
Note: PK evaluation for the givinostat 75 mg and 50 mg b.i.d. dose groups for Cycle 1 Day 1 was not applicable (since all received givinostat 100 mg b.i.d.). Additionally, concentration data for ITF2375 (Cycle 1 Day 28) in the 50 mg b.i.d. dose group was not available for PK analysis. |
Measure: | Assessment of AUClast of Givinostat and Metabolites (ITF2374 and ITF2375) in Part B of the Study |
Time Frame: | Blood samples were collected in Part B on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 2 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose. |
Safety Issue: | |
Description: | PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of AUClast following administration of givinostat for 2 cycles in Part B. PK calculations were performed by standard non-compartmental analysis and AUClast was calculated using the linear trapezoidal rule. Following definition of the MTD in Part A, during Part B Cycle 1, givinostat was administered at 100 mg b.i.d. and during Part B Cycle 2 was administered at 100 mg, 75 mg and 50 mg b.i.d. (since dose reductions due to TEAEs were allowed from Cycle 2 onwards, as per protocol). Results are reported for Cycle 1 Day 1 and Cycle 2 Day 28 for the for the doses administered during Part B.
Note: PK evaluation for the givinostat 75 mg and 50 mg b.i.d. dose groups for Cycle 1 Day 1 was not applicable (since all received givinostat 100 mg b.i.d.). Additionally, concentration data for ITF2375 (Cycle 1 Day 28) in the 50 mg b.i.d. dose group was not available for PK analysis. |
Measure: | Assessment of AUC0-12 of Givinostat and Metabolites (ITF2374 and ITF2375) in Part B of the Study |
Time Frame: | Blood samples were collected in Part B on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 2 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose. |
Safety Issue: | |
Description: | PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of AUC0-12 following administration of givinostat for 2 cycles in Part B. PK calculations were performed by standard non-compartmental analysis and AUClast was calculated using the linear trapezoidal rule. Following definition of the MTD in Part A, during Part B Cycle 1, givinostat was administered at 100 mg b.i.d. and during Part B Cycle 2 was administered at 100 mg, 75 mg and 50 mg b.i.d. (since dose reductions due to TEAEs were allowed from Cycle 2 onwards, as per protocol). Results are reported for Cycle 1 Day 1 and Cycle 2 Day 28 for the doses administered during Part B.
Note: PK evaluation for the givinostat 75 mg and 50 mg b.i.d. dose groups for Cycle 1 Day 1 was not applicable (since all received givinostat 100 mg b.i.d.). Additionally, concentration data for ITF2374 (Cycle 1 Day 28) across all dose groups and for ITF2375 in the 50 mg b.i.d. dose group was not available for PK analysis. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Italfarmaco |
Trial Keywords
- chronic myeloproliferative neoplasms
- Polycythemia Vera
- Essential Thrombocythemia
- Primary Myelofibrosis
- Post-Polycythemia Vera Myelofibrosis
- Post-Essential Thrombocythemia Myelofibrosis
- Givinostat
Last Updated
July 30, 2019