A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 134
- 试验地点
- 95
- 主要终点
- Percentage of participants with treatment-emergent adverse events (AES)
研究概览
简要总结
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 and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).
详细描述
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.
This roll-over study will not include a screening phase, participants will directly transfer at the completion of the parent study. Eligible participants will start receiving ribociclib in combination with other drugs (as per parent protocol) only after they have signed the Informed Consent and have met the selection criteria for this roll-over study.
Participants should return to the study center for resupply of the study medication and for safety and clinical benefit assessment, at a minimum, every 24 weeks, or more frequently at any given time required as per local practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Participant is 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).
- •Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
- •Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study.
- •Participant must have evidence of clinical benefit as determined by the Investigator.
排除标准
- •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.
- •Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume).
- •Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria).
- •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:
- •Total abstinence
- •Female sterilization
- •Male partner sterilization
- •Placement of an intrauterine device (IUD)
- •Male contraception during ribociclib use by male participants is not required unless it is necessary due to the safety profile of other medications a participant is taking or by local regulations.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Ribociclib
Participants will receive ribociclib with other drugs at the same dose and schedule as in the parent study. Treatment continues until clinical benefit ends (e.g., disease progression), unacceptable toxicity, consent withdrawal, protocol non-compliance, transition to alternative therapy or access program, can receive ribociclib through prescription (commercially availability and reimbursement of ribociclib except for U.S. participants from CLEE011A2404).
干预措施: Tamoxifen (Drug)
Ribociclib
Participants will receive ribociclib with other drugs at the same dose and schedule as in the parent study. Treatment continues until clinical benefit ends (e.g., disease progression), unacceptable toxicity, consent withdrawal, protocol non-compliance, transition to alternative therapy or access program, can receive ribociclib through prescription (commercially availability and reimbursement of ribociclib except for U.S. participants from CLEE011A2404).
干预措施: Fulvestrant (Drug)
Ribociclib
Participants will receive ribociclib with other drugs at the same dose and schedule as in the parent study. Treatment continues until clinical benefit ends (e.g., disease progression), unacceptable toxicity, consent withdrawal, protocol non-compliance, transition to alternative therapy or access program, can receive ribociclib through prescription (commercially availability and reimbursement of ribociclib except for U.S. participants from CLEE011A2404).
干预措施: Goserelin (Drug)
Ribociclib
Participants will receive ribociclib with other drugs at the same dose and schedule as in the parent study. Treatment continues until clinical benefit ends (e.g., disease progression), unacceptable toxicity, consent withdrawal, protocol non-compliance, transition to alternative therapy or access program, can receive ribociclib through prescription (commercially availability and reimbursement of ribociclib except for U.S. participants from CLEE011A2404).
干预措施: Ribociclib (Drug)
Ribociclib
Participants will receive ribociclib with other drugs at the same dose and schedule as in the parent study. Treatment continues until clinical benefit ends (e.g., disease progression), unacceptable toxicity, consent withdrawal, protocol non-compliance, transition to alternative therapy or access program, can receive ribociclib through prescription (commercially availability and reimbursement of ribociclib except for U.S. participants from CLEE011A2404).
干预措施: Letrozole (Drug)
Ribociclib
Participants will receive ribociclib with other drugs at the same dose and schedule as in the parent study. Treatment continues until clinical benefit ends (e.g., disease progression), unacceptable toxicity, consent withdrawal, protocol non-compliance, transition to alternative therapy or access program, can receive ribociclib through prescription (commercially availability and reimbursement of ribociclib except for U.S. participants from CLEE011A2404).
干预措施: Anastrozole (Drug)
结局指标
主要结局
Percentage of participants with treatment-emergent adverse events (AES)
时间窗: From day of first dose of study medication to 30 days after last dose of study medication, up to 8 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
次要结局
- Clinical benefit rate(Up to 8 years)