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Trial details
Roll-over Study to Allow Continued Access to Ribociclib
Current status:
Approved
|
Date registered:
18/07/2024
Trial version(s)
History: 17/08/2022
History: 17/08/2022
History: 17/08/2022
History: 17/08/2022
History: 17/08/2022
Current: 17/08/2022
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2022095114
Protocol number
CLEE011A2412B
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Roll-over Study to Allow Continued Access to Ribociclib
Acronym
Scientific title
A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study
Acronym
Brief summary of the study: English
This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.
Brief summary of the study: Arabic
هذه دراسة تمديد مفتوحة التسمية ومتعددة المراكز لتقييم السلامة طويلة المدى لريبوسيكليب بالاشتراك مع أدوية أخرى في المشاركين الذين يشاركون في دراسة عالمية ترعاها شركة نوفارتيس، والتي أوفت بمتطلبات هدفها الأساسي (أهدافها)، ومن يعتقد طبيب الدراسة أنه سيستفيد من استمرار العلاج.
Health conditions/problem studied: Specify
Metastatic Breast Cancer
Interventions: Specify
Drug: Ribociclib (Participants continue ribociclib as was administered in their parent study) Drug: Letrozole (Participants continue ribociclib in combination with letrozole as was administered in their parent study) Drug: Anastrozole (Participants continue ribociclib in combination with anastrozole as was administered in their parent study) Drug: Goserelin (Participants continue ribociclib in combination with goserelin as was administered in their parent study) Drug: Tamoxifen (Participants continue ribociclib in combination with tamoxifen as was administered in their parent study) Drug: Fulvestrant (All participants continue ribociclib in combination with fulvestrant as was administered in their parent study)
Key inclusion and exclusion criteria: Inclusion criteria
1. Currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s) 2. Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study 3. Currently has evidence of clinical benefit as determined by the Investigator
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
1. Permanent discontinuation of ribociclib in the parent study 2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
N/A
Study design: Masking
Open (masking not used)
Study design: Control
Uncontrolled
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
US, EU, and other countries
Name of IMP
Ribociclib
Year of authorization
2017
Month of authorization
1
Type of IMP
Others
Type of IMP: Specify
CDK46 inhibitor
Pharmaceutical class
highly selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6)
Therapeutic indication
Metastatic Breast Cancer
Therapeutic benefit
continued treatment to participants who are currently receiving ribociclib
Biospecimen retention
None retained
Biospecimen description
NA
Target sample size
5
Actual enrollment target size
5
Date of first enrollment: Type
Actual
Date of first enrollment: Date
15/12/2022
Date of study closure: Type
Actual
Date of study closure: Date
16/02/2028
Recruitment status
Complete
Date of completion
03/01/2023
IPD sharing statement plan
Yes
IPD sharing statement description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT05161195?term=clee011A2412B&draw=2&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
clinicaltrials.gov
NCT05161195
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
Jawad
Makarem
Al Chouf
Lebanon
+961 3 484288
jawad.Makarem@awmedicalvillage.org
Ain Wazein Medical Village
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@ fattal.com.lb
Khalil Fattal et Fils s.a.l
Public
Nagi
El Saghir
Beirut
Lebanon
+961 3 827955
ns23@aub.edu.lb
American University of Beirut Medical Center
Public
Joseph
Kattan
Beirut
Lebanon
+961 3 635913
jkattan62@hotmail.com
Hotel Dieu de France
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
American University of Beirut Medical Center
Nagi El Saghir
Hematology Oncology
Approved
Ain Wazein Medical Village
Jawad Makarem
Hematology Oncology
Approved
Hotel Dieu de France
Joseph Kattan
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
05/09/2022
Rami Mahfouz
rm11@aub.edu.lb
+961 (0) 1 350 000 ext:5445
Ain w Zein Medical Village
25/08/2022
Hayat Kamaleddine
irb@awmedicalvillage.org
+961 (0) 5 509 001 ext 2014
Hotel Dieu de France
12/08/2022
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Countries of Recruitment
Name
Lebanon
Poland
Singapore
United States of America
Brazil
France
Greece
China
Italy
Japan
Republic of Korea
Mexico
Portugal
South Africa
Spain
Taiwan
Turkey
Health Conditions or Problems Studied
Condition
Code
Keyword
Metastatic Breast Cancer
Malignant neoplasm of breast (C50)
Metastatic Breast Cancer
Interventions
Intervention
Description
Keyword
ICF, IMP administration, local Labs
ICF, IMP administration, local Labs
ICF, IMP administration, local Labs
Primary Outcomes
Name
Time points
Measure
Percentage of participants with treatment-emergent adverse events (AES)
From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years
The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment
Key Secondary Outcomes
Name
Time points
Measure
Clinical benefit rate
Up to 5 years
Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits
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
PA01 IRB Approval - HDF and AWZ
26/06/2024
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