Toggle navigation
Lebanon Clinical Trials Registry
Home
About Us
FAQs
Contact Us
Search Trials
Register
Log in
User Guide
Trial details
You are here
Home
Search Trials
Trial details
Trial details
Rollover An Open Label, Multi-center, Phase IV Rollover Protocol for Patients Who Have Completed a Global Novartis or Incyte Sponsored Ruxolitinib (INC424) or Ruxolitinib and Panobinostat (LBH589) Combination Study and Are Judged by the Investigator to Benefit From Continued Treatment
Current status:
Approved
|
Date registered:
15/12/2020
Trial version(s)
History: 02/01/2020
Current: 02/01/2020
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2020011380
Protocol number
CINC424A2X01B
MOH registration number
10517/ص
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
This trial was previously submitted prior to LBCTR
Date of registration in national regulatory agency
19/11/2015
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Rollover An Open Label, Multi-center, Phase IV Rollover Protocol for Patients Who Have Completed a Global Novartis or Incyte Sponsored Ruxolitinib (INC424) or Ruxolitinib and Panobinostat (LBH589) Combination Study and Are Judged by the Investigator to Benefit From Continued Treatment
Acronym
Scientific title
An open label, multi-center, Phase IV roll-over protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study and are judged by the investigator to benefit from continued treatment
Acronym
Brief summary of the study: English
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.
Brief summary of the study: Arabic
بروتوكول ممدّد مفتوح اللصاقة، متعدد المراكز، في المرحلة الرابعة للمرضى الذين أتمّوا دراسة مسبقة شاملة برعاية نوفارتيس أو إنسايت حول روكسوليتينيب (INC424) ويستفيدون برأي الباحث من استمرار العلاج
Health conditions/problem studied: Specify
Splenomegaly
Interventions: Specify
INC424/ruxolitinib/Jakavi
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion Criteria: 1.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, is 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.Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures 5.Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat 6.Written informed consent obtained prior to enrolling in roll-over 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.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
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 local country 3.Patient has participated in a combination trial (other than the specified panobinostat and ruxolitinib combination trial) where ruxolitinib was dispensed in combination with another study medication and the patient is still receiving combination therapy. 4.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG lab test. 5.Women of child-bearing potential, unless they are using highly effective methods of contraception throughout the study duration inclusive of the 30-day safety follow up. 6.Female patients between ≥ 12 and < 18 years of age and of childbearing potential 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.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
N/A: Single arm study
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
4
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
countries worldwide
Name of IMP
Jakavi
Year of authorization
2015
Month of authorization
4
Type of IMP
Others
Type of IMP: Specify
JAK inhibitor
Pharmaceutical class
JAK inhibitor
Therapeutic indication
To evaluate clinical benefit as assessed by the investigator
Therapeutic benefit
To evaluate clinical benefit as assessed by the investigator
Biospecimen retention
None retained
Biospecimen description
Not applicable
Target sample size
7
Actual enrollment target size
4
Date of first enrollment: Type
Actual
Date of first enrollment: Date
28/01/2016
Date of study closure: Type
Actual
Date of study closure: Date
22/10/2020
Recruitment status
Complete
Date of completion
11/02/2016
IPD sharing statement plan
No
IPD sharing statement description
Not provided
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT02386800
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
ClinicalTrials.gov
NCT02386800
Sources of Monetary or Material Support
Name
Novartis Pharmaceuticals
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Ali
Taher
Beirut
Lebanon
01350000 ext 7908
ataher@aub.edu.lb
American University of Beirut Medical Center
Scientific
Hind
Kairallah
Sinelfil
Lebanon
+961 1 512002 Ext. 271
Hind.khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
American University of Beirut Medical Center
Prof. Ali Taher
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
04/06/2015
Fuad Ziyadeh
fz05@aub.edu.lb
00961350000 ext 5445
Countries of Recruitment
Name
Lebanon
Australia
Belgium
Bulgaria
Chile
China
Germany
Greece
Hungary
Italy
Republic of Korea
Mexico
Portugal
Russian Federation
South Africa
Spain
Sweden
Thailand
Turkey
Health Conditions or Problems Studied
Condition
Code
Keyword
Splenomegaly
Splenomegaly, not elsewhere classified (R16.1)
Splenomegaly
Interventions
Intervention
Description
Keyword
ICF, Physical Examination, IMP administration
ICF, Physical Examination, IMP administration
ICF, Physical Examination, IMP administration
Primary Outcomes
Name
Time points
Measure
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: through study completion estimated to be approximately 10 years ]
through study completion
Adverse Events
Key Secondary Outcomes
Name
Time points
Measure
1.To evaluate clinical benefit as assessed by the investigator
approximately 10 years
clinical benefit as assessed by the investigator
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Study close out notification and related documents
13/12/2020
Download as PDF
Save a PDF copy of the summary of the trial