CINC424A2X01B Rollover Protocol

Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies

ClinicalTrials.gov Identifier: NCT02386800

Novartis Reference Number: CINC424A2X01B

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This roll-over protocol allows patients who are still receiving clinical benefit to continue to be treated from multiple protocols in one program spanning multiple indications during the completion of the parent study/(ies). The population for the roll-over study should be consistent with the population defined in the program parent study/(ies). The primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a Novartis GDD&GMA/Incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. Efficacy parameters would not be measured; however safety data and an evaluation of clinical benefit will be collected.

Patients who have completed a prior study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat and who are assessed by the Investigator to continue to benefit from ongoing treatment will be eligible.

Condition 
Primary Myelofibrosis
Chronic Idiopathic Myelofibrosis
Post Polycythemia Vera Myelofibrosis
Post Essential Thrombocythaemia Myelofibrosis
Steroid Refractory Graft Versus Host Disease
Phase 
Phase 4
Overall status 
Recruiting
Enrollment count 
356 participants
Start date 
Mar 05, 2015
Completion date 
Sep 17, 2025
Gender 
All
Age(s)
1 Years and older (Child, Adult, Older Adult)

Interventions

Drug
ruxolitinib tablets or oral pediatric formulation, panobinostat capsules
ruxolitinib tablets or oral pediatric formulation, panobinostat capsules
Drug
ruxolitinib tablets or oral pediatric formulation
ruxolitinib tablets or oral pediatric formulation

Eligibility Criteria

Inclusion criteria:

Patients eligible for inclusion in this study have to meet all of the following criteria:

Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study (where Incyte can delegate the sponsorship to a preferred CRO, if applicable) that is approved to enroll into this rollover study, and are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol.
Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator
Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat
Written informed consent obtained prior to enrolling in rollover study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Note 1: If the patient is a minor, the parent who signs the informed consent for the minor must be a legally recognized parent or guardian. Where deemed appropriate by the clinician, and the child's parent or guardian, the child will also be included in the all discussions about the trials and the minor aged 12 and above assent will be obtained. The parent or guardian will sign on the designated line on the ICF attesting to the fact that the child had given consent.

Note 2: if the minor is an adolescent female, she will be informed during the assent process that for safety purpose, a pregnancy test is required. She will also be told that if it is positive, she will be counseled and will be assisted in telling her parents. If the minor does not want to proceed, she will be advised not to sign consent and her enrollment in this protocol will end.

Exclusion criteria:

Patients eligible for this study must not meet any of the following criteria:

Patient has been permanently discontinued from study treatment in the parent study due to any reason.
Patient's indication is currently approved and reimbursed in the local country.
Patient has participated in a combination trial other than the panobinostat and ruxolitinib combination trial (CLBH589X2106), where ruxolitinib was dispensed in combination with another study medication and until the termination of gestation, confirmed by a positive hCG laboratory test.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

Female patients between ≥ 12 and < 18 years of age and 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 as defined below, throughout the study and for up to 30 days after stopping treatment.

Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study duration inclusive of the 30-day safety follow up. Highly effective contraception methods include:

Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.

In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential.

For patients on the combination of ruxolitinib and panobinostat:

Women of childbearing potential unwilling to use highly effective methods of contraception during dosing and for 3 months (female patients of childbearing potential)
Female sexual partner(s) of childbearing potential of male participants unwilling to use highly effective methods of contraception during dosing and for 6 months after stopping.
Women of childbearing potential who use hormonal contraceptives and additionally unwilling to use a barrier method for birth control.Sexually active males (including vasectomised men) unwilling to use barrier contraception (condom with spermicide) during intercourse and for 6 months after stopping treatment (in order to prevent delivery of the drug via seminal fluid).

Study Locations

Australia
Novartis Investigative Site
Completed
Darlinghurst, 2010
New South Wales
Australia
Novartis Investigative Site
Completed
St Leonards, 2065
New South Wales
Australia
Novartis Investigative Site
Completed
Herston, 4029
Queensland
Australia
Novartis Investigative Site
Completed
Wooloongabba, 4102
Queensland
Australia
Novartis Investigative Site
Completed
Bedford Park, 5041
South Australia
Australia
Novartis Investigative Site
Completed
Box Hill, 3128
Victoria
Australia
Novartis Investigative Site
Completed
Clayton, 3168
Victoria
Australia
Novartis Investigative Site
Completed
Franston, 3199
Victoria
Australia
Novartis Investigative Site
Completed
Perth, 6000
Western Australia
Australia
Belgium
Novartis Investigative Site
Recruiting
Antwerpen, 2060
-
Belgium
Novartis Investigative Site
Recruiting
Brugge, 8000
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Novartis Investigative Site
Recruiting
Liege, 4000
-
Belgium
Bulgaria
Novartis Investigative Site
Recruiting
Pleven, 5800
-
Bulgaria
Novartis Investigative Site
Recruiting
Plovdiv, 4002
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1413
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1431
-
Bulgaria
Chile
Novartis Investigative Site
Recruiting
Vina del Mar, 2540364
Valparaiso
Chile
Novartis Investigative Site
Recruiting
Santiago, 8420383
-
Chile
Novartis Investigative Site
Recruiting
Santiago,
-
Chile
China
Novartis Investigative Site
Recruiting
Beijing, 100730
Beijing
China
Novartis Investigative Site
Recruiting
Hangzhou, 310003
Zhejiang
China
Germany
Novartis Investigative Site
Active, not recruiting
Aachen, 52074
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Magdeburg, 39120
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Active, not recruiting
Ulm, 89081
-
Germany
Greece
Novartis Investigative Site
Completed
Goudi-Athens, 115 27
GR
Greece
Novartis Investigative Site
Recruiting
Patras, 265 00
-
Greece
Hungary
Novartis Investigative Site
Completed
Budapest, 1097
-
Hungary
Novartis Investigative Site
Completed
Debrecen, 4032
-
Hungary
Novartis Investigative Site
Completed
Kaposvar, 7400
-
Hungary
Novartis Investigative Site
Completed
Kecskemet, 6001
-
Hungary
Novartis Investigative Site
Completed
Szeged, H 6725
-
Hungary
Novartis Investigative Site
Completed
Szombathely, 9700
-
Hungary
Israel
Novartis Investigative Site
Recruiting
Afula, 1834111
-
Israel
Novartis Investigative Site
Recruiting
Jerusalem, 91120
-
Israel
Italy
Novartis Investigative Site
Completed
Bari, 70124
BA
Italy
Novartis Investigative Site
Recruiting
Firenze, 50134
FI
Italy
Novartis Investigative Site
Completed
Milano, 20122
MI
Italy
Novartis Investigative Site
Recruiting
Milano, 20162
MI
Italy
Novartis Investigative Site
Completed
Palermo, 90146
PA
Italy
Novartis Investigative Site
Recruiting
Pavia, 27100
PV
Italy
Novartis Investigative Site
Recruiting
Reggio Calabria, 89124
RC
Italy
Novartis Investigative Site
Completed
Roma, 00161
RM
Italy
Novartis Investigative Site
Completed
Orbassano, 10043
TO
Italy
Novartis Investigative Site
Recruiting
Varese, 21100
VA
Italy
Novartis Investigative Site
Completed
Napoli, 80131
-
Italy
Japan
Novartis Investigative Site
Recruiting
Nagoya, 466 8560
Aichi
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03722
-
Korea, Republic of
Lebanon
Novartis Investigative Site
Completed
Beirut, 1107 2020
-
Lebanon
Mexico
Novartis Investigative Site
Active, not recruiting
Monterrey, 64718
Nuevo Leon
Mexico
Portugal
Novartis Investigative Site
Active, not recruiting
Lisboa, 1099 023
-
Portugal
Novartis Investigative Site
Active, not recruiting
Lisboa, 1649-035
-
Portugal
Russian Federation
Novartis Investigative Site
Active, not recruiting
Moscow, 125167
-
Russian Federation
Novartis Investigative Site
Completed
Moscow, 129110
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Petrozavodsk, 185019
-
Russian Federation
South Africa
Novartis Investigative Site
Completed
Soweto, 2013
Gauteng
South Africa
Novartis Investigative Site
Recruiting
Cape Town, 7800
Western Province
South Africa
Novartis Investigative Site
Completed
Pretoria, 0027
-
South Africa
Novartis Investigative Site
Recruiting
Pretoria, 0044
-
South Africa
Spain
Novartis Investigative Site
Completed
Salamanca, 37007
Castilla Y Leon
Spain
Novartis Investigative Site
Completed
Barcelona, 08003
Catalunya
Spain
Novartis Investigative Site
Completed
Pamplona, 31008
Navarra
Spain
Sweden
Novartis Investigative Site
Active, not recruiting
Huddinge, SE-14186
-
Sweden
Novartis Investigative Site
Active, not recruiting
Lulea, SE 971 80
-
Sweden
Novartis Investigative Site
Recruiting
Lund, SE-221 85
-
Sweden
Novartis Investigative Site
Recruiting
Uddevalla, 451 80
-
Sweden
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10700
Bangkoknoi
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10700
-
Thailand
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06100
Sihhiye
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34093
-
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35040
-
Turkey
Novartis Investigative Site
Recruiting
Talas / Kayseri, 38039
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 
Name: 
Novartis Pharmaceuticals
Phone: 
+81337978748
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]