CINC424A2X01B Rollover Protocol
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 1 Month and Over |
| Gender | All |
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. KeyExclusion 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.Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02386800 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 4 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Novartis Pharmaceuticals |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Novartis Pharmaceuticals |
| Principal Investigator Affiliation | Novartis Pharmaceuticals |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Australia, Belgium, Bulgaria, Chile, China, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, Sweden, Thailand, Turkey |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Primary Myelofibrosis, Polycythemia Vera, Graft Versus Host Disease, Acute Myeloid Leukemia, Thalassemia |
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.
Arms
Experimental: Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination
All participants will receive either ruxolitinib monotherapy or ruxolitinib in combination with panobinostat, at the same dose/schedule that they were taking in the parent study.
Interventions
Drug: - ruxolitinib
ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
Drug: - panobinostat
panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Completed
Address
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
Site Contact
Status
Completed
Address
Novartis Investigative Site
St Leonards, New South Wales, 2065
Site Contact
Status
Completed
Address
Novartis Investigative Site
Herston, Queensland, 4029
Site Contact
Status
Completed
Address
Novartis Investigative Site
Wooloongabba, Queensland, 4102
Site Contact
Status
Completed
Address
Novartis Investigative Site
Bedford Park, South Australia, 5041
Site Contact
Status
Completed
Address
Novartis Investigative Site
Box Hill, Victoria, 3128
Site Contact
Status
Completed
Address
Novartis Investigative Site
Clayton, Victoria, 3168
Site Contact
Status
Completed
Address
Novartis Investigative Site
Franston, Victoria, 3199
Site Contact
Status
Completed
Address
Novartis Investigative Site
Perth, Western Australia, 6000
Site Contact
Status
Completed
Address
Novartis Investigative Site
Santiago, RM, 7500922
Site Contact
Status
Completed
Address
Novartis Investigative Site
Vina del Mar, Valparaiso, 2540364
Site Contact
Status
Completed
Address
Novartis Investigative Site
Hangzhou, Zhejiang, 310003
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Beijing, , 100730
Site Contact
Status
Withdrawn
Address
Novartis Investigative Site
Copenhagen, , DK-2100
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Aachen, , 52074
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Magdeburg, , 39120
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Mainz, , 55131
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Pune, Maharashtra, 411004
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Brescia, BS, 25123
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
San Giovanni Rotondo, FG, 71013
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Firenze, FI, 50134
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Pavia, PV, 27100
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Reggio Calabria, RC, 89124
Site Contact
Status
Completed
Address
Novartis Investigative Site
Nagoya, Aichi, 453-8511
Site Contact
Status
Recruiting
Address
Novartis Investigative Site
Nagoya, Aichi, 466 8560
Site Contact
Status
Completed
Address
Novartis Investigative Site
Fukuoka city, Fukuoka, 812-8582
Site Contact
Status
Completed
Address
Novartis Investigative Site
Sapporo city, Hokkaido, 060 8648
Site Contact
Status
Completed
Address
Novartis Investigative Site
Isehara, Kanagawa, 259-1193
Site Contact
Status
Completed
Address
Novartis Investigative Site
Suita, Osaka, 565 0871
Site Contact
Status
Completed
Address
Novartis Investigative Site
Bunkyo ku, Tokyo, 113-8677
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Seoul, , 03080
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Seoul, , 03722
Site Contact
Status
Completed
Address
Novartis Investigative Site
Monterrey, Nuevo Leon, 64718
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Gliwice, Slaskie, 44-101
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Wroclaw, , 50 367
Site Contact
Status
Completed
Address
Novartis Investigative Site
Petrozavodsk, , 185019
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Saint Petersburg, , 197022
Site Contact
Status
Completed
Address
Novartis Investigative Site
Soweto, Gauteng, 2013
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Cape Town, Western Province, 7800
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Pretoria, , 0044
Site Contact
Status
Completed
Address
Novartis Investigative Site
Salamanca, Castilla Y Leon, 37007
Site Contact
Status
Completed
Address
Novartis Investigative Site
Barcelona, Catalunya, 08003
Site Contact
Status
Completed
Address
Novartis Investigative Site
Pamplona, Navarra, 31008
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Huddinge, , SE-14186
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Lulea, , SE 971 80
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Lund, , SE-221 85
Site Contact
Status
Active, not recruiting
Address
Novartis Investigative Site
Uddevalla, , 451 80
Site Contact
Status
Completed
Address
Novartis Investigative Site
Ankara, Sihhiye, 06100
Site Contact
Status
Completed
Address
Novartis Investigative Site
Talas / Kayseri, , 38039
Site Contact
