| CTRI Number |
CTRI/2024/08/072213 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to allow continued access to ribociclib |
|
Scientific Title of Study
|
A post-trial access roll-over study to allow access to ribociclib (LEE011) for patients who are on ribociclib treatment in Novartis-sponsored study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2021-005184-42 |
EudraCT |
| CLEE011A2412B, 00 (Original Protocol), 19-Nov-2021 |
Protocol Number |
| NCT05161195 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murugananthan K |
| Designation |
SSO country head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 7 floor Inspire BKC GBlock BKC Main Road
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murugananthan K |
| Designation |
SSO country head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 7 floor Inspire BKC GBlock BKC Main Road
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Murugananthan K |
| Designation |
SSO country head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 7 floor Inspire BKC GBlock BKC Main Road
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Novartis Campus 4056 – Basel, Switzerland |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
7 floor, Inspire BKC, G Block, BKC Main Road, Bandra KurlaComplex, Bandra (East), Mumbai– 400051,India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Brazil
Canada
China
Costa Rica
Greece
Hong Kong
India
Italy
Japan
Lebanon
Lithuania
Mexico
Peru
Poland
Portugal
Republic of Korea
Singapore
South Africa
Spain
Taiwan
Turkey
United States of America
Viet Nam |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dinesh Chandra Doval |
Rajiv Gandhi Cancer Institute and Research Centre, |
Department of oncology, Sector 5, Rohini, New Delhi-110085
New Delhi
DELHI |
9810836274
dcdoval@gmail.com |
| Prof Dr Ghanashyam Biswas |
Sparsh Hospital and Critical Care (P |
Sparsh Hospital and Critical Care (P) Ltd, A/407/ Saheed Nagar, Bhubaneswar, Odisha, India, 751007
Baleshwar
ORISSA |
916742540183
drgbiswas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sparsh Hospital |
Approved |
| Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
ribociclib |
Ribociclib will be given orally once a day on Days 1-21 of each 28-day cycle. Days 22-28 will be a “rest†from ribociclib. Ribociclib will be given for a long time till the patient is no longer benefitting or discontinued from treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are currently receiving treatment with ribociclib in combination with other drugs within a Novartis sponsored global study, that has fulfilled the requirements for its primary objective(s), and who, in the opinion of the Investigator, would benefit from continued treatment but are unable to access the study treatments outside of this study |
|
| ExclusionCriteria |
| Details |
1. Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol.
2. Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligbility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume).
3. Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria).
4. Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment. Highly effective contraception methods include:
a) Total abstinence
b) Female sterilization
c) Male partner sterilization
d) Placement of an intrauterine device (IUD)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| occurrence of adverse events of ribociclib |
Week 1 Day 1, Every 24 wks, Continuous up to 30 days after the last dose of study treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinical benefit as assessed by the Investigator. |
Week 1 Day 1, Every 24 wks untill no benefit seen. |
|
|
Target Sample Size
|
Total Sample Size="137"
Sample Size from India="2"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/07/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="7"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
purpose of this study is to assess the long-term safety of ribociclib (LEE011)
in combination with other drugs and provide post-trial access (PTA) to
participants who are currently receiving treatment with ribociclib in
combination with other drugs in a Novartis sponsored global study that has
reached its primary objective(s). Participants
who are currently receiving treatment with ribociclib in combination with other
drugs within a Novartis sponsored global study, that has fulfilled the
requirements for its primary objective(s), and who, in the opinion of the
Investigator, would benefit from continued treatment but are unable to access
the study treatments outside of this study |