A study to allow continued access to ribociclib
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2024/08/072213
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method