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Active (not recruiting) Phase 4 NCT02386800

CINC424A2X01B Rollover Protocol

Phase 4 – monitoring after market approval
Conditions: Primary Myelofibrosis Polycythemia Vera Graft Versus Host Disease Acute Myeloid Leukemia Thalassemia

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.
Description
This roll-over protocol allows patients from multiple protocols, who are still receiving clinical benefit, to continue their treatment in one study that covers multiple indications. The population for the roll-over study should be consistent with the population defined in the parent studies. The primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a Novartis or Incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. Efficacy parameters will not be measured; however safety data and an evaluation of clinical benefit will be collected.
Who can participate
Key Inclusion criteria: 1. Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol. 2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements 4. Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat Key Exclusion criteria: 1. Patient has been permanently discontinued from study treatment in the parent study due to any reason. 2. Patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. 3. Pregnant or nursing (lactating) women. 4. Female patients of childbearing potential (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment. Other protocol-defined Inclusion / Exclusion criteria may apply.
Locations 24
Australia (1)
Novartis Investigative Site
Darlinghurst , New South Wales
Belgium (1)
Novartis Investigative Site
Leuven , Vlaams Brabant
Bulgaria (1)
Novartis Investigative Site
Pleven
Canada (1)
Novartis Investigative Site
Toronto , Ontario
Chile (1)
Novartis Investigative Site
Santiago , RM
China (1)
Novartis Investigative Site
Hangzhou , Zhejiang
France (1)
Novartis Investigative Site
Paris
Germany (1)
Novartis Investigative Site
Dresden , Saxony
Greece (1)
Novartis Investigative Site
Athens
Hungary (1)
Novartis Investigative Site
Debrecen , Hajdu Bihar Megye
India (1)
Novartis Investigative Site
Pune , Maharashtra
Israel (1)
Novartis Investigative Site
Afula
Italy (1)
Novartis Investigative Site
Ancona , AN
Japan (1)
Novartis Investigative Site
Nagoya , Aichi-ken
Lebanon (1)
Novartis Investigative Site
Beirut
Mexico (1)
Novartis Investigative Site
Monterrey , Nuevo León
Poland (1)
Novartis Investigative Site
Gliwice , Silesian Voivodeship
Russia (1)
Novartis Investigative Site
Moscow
South Africa (1)
Novartis Investigative Site
Pretoria , Gauteng
South Korea (1)
Novartis Investigative Site
Seoul , Korea
Spain (1)
Novartis Investigative Site
Barcelona , Catalonia
Sweden (1)
Novartis Investigative Site
Huddinge
Thailand (1)
Novartis Investigative Site
Bangkok
Turkey (1)
Novartis Investigative Site
Istanbul , Fatih
Technical details
Status
Active (not recruiting)
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Month
Maximum age
100 Years
Healthy volunteers
No
Start date
05.03.2015
Completion date
16.09.2027
Registry ID
NCT02386800
Source
anzctr
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