Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT01761968 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
NotablePrimary completion date: Jun 2022 to Jun 2025Completion date: Dec 2022 to Dec 2025 · Site details revised at 1 of 15 sitesv22Show 2 more changesShow less
Completion date: Dec 2022 to Dec 2025
Site details revised at 1 of 15 sites
Show 20 earlier versionsHide 20 earlier versions
MinorStudy sites: 16 to 15v21
NotablePrimary completion date: Jun 2020 to Jun 2022Trial status: Recruiting to Active, Not Recruiting · Completion date: Dec 2020 to Dec 2022 · Site details revised at 16 of 16 sitesv20Show 3 more changesShow less
Trial status: Recruiting to Active, Not Recruiting
Completion date: Dec 2020 to Dec 2022
Site details revised at 16 of 16 sites
MinorSite contacts updated at 1 of 16 sitesv19
MinorSite contacts updated at 10 of 16 sitesv18
MinorSite contacts updated at 1 of 16 sitesv17
MinorStudy sites: 14 to 16v16
MinorSite details revised at 3 of 14 sitesv15
MinorStudy sites: 13 to 14v14
MinorStudy sites: 12 to 13v13
NotableEnrollment target: 60 to 90Study sites: 10 to 12 · Primary completion date: Dec 2019 to Jun 2020 · Completion date: Mar 2020 to Dec 2020 · 2 morev12Show 5 more changesShow less
NotableEnrollment target: 30 to 60Primary completion date: Mar 2018 to Dec 2019 · Study sites: 9 to 10 · Completion date: Mar 2019 to Mar 2020 · 1 morev11Show 4 more changesShow less
Minor2 versionsRe-verified since Jun 25, 2014, no change to tracked fieldsv9-v10
NotablePrimary completion date: Mar 2015 to Mar 2018Completion date: Mar 2016 to Mar 2019 · Site details revised at 2 of 9 sitesv8Show 2 more changesShow less
Completion date: Mar 2016 to Mar 2019
Site details revised at 2 of 9 sites
MinorSite details revised at 2 of 9 sitesv7
MinorSite contacts updated at 2 of 9 sitesv6
MinorEligibility criteria shortened, about 8 wordsStudy title shortened, about 2 wordsv5Show 1 more changeShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, open label, long-term study testing the long-term safety, tolerability and efficacy of givinostat in patients with Polycythemia Vera, Essential Thrombocythemia, primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis following core protocols in chronic myeloproliferative neoplasms and/or patient-named compassionate use program (if regulated/allowed by the local regulations, e.g. for Italy D.M. 8/5/2003 "Uso terapeutico di medicinale sottoposto a sperimentazione clinica" published on G.U. n. 173 of 28 July 2003, and the following amendments). Patients will continue at their last tolerable dose and treatment schedule of givinostat monotherapy. If patients previously received givinostat in combination with other drugs during a core protocol or a compassionate use program (if regulated/allowed by the local regulations, e.g. for Italy D.M. 8/5/2003 "Uso terapeutico di medicinale sottoposto a sperimentazione clinica" published on G.U. n. 173 of 28 July 2003, and the following amendments), they will be treated at the last tolerable dose of the combination. Assessment of safety and efficacy will be performed at each quarterly visit and each visit will also include laboratory tests and ECG examination. During the visits the clinical benefit will be assessed by Investigator according to the revised European LeukemiaNet response criteria (for PV and ET) and EUMNET response criteria (for MF). The dose of Givinostat will be modified for protocol specified toxicities. The treatment may continue up to Marketing Authorization of givinostat, currently planned in the next 5 years (note: only for Germany, this long-term study is initially limited up to 2 years of treatment). Patients may discontinue study treatment at any time and remain on study therapy as long as they derive clinical benefit. Safety will be monitored at each visit throughout the entire duration of the study. In case the approved label will not cover the whole study population, givinostat will be provided by the Sponsor to those patients not fulfilling the criteria for the approved label of the drug that are still deriving benefit from givinostat at the time of its commercial availability.