The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.
Written informed consent/assent, according to local guidelines, signed by the participants and/or by the parents or legal guardian prior to enrolling in the roll-over study.
Participant currently enrolled in a Novartis-sponsored study, is currently receiving alpelisib as a single agent or in combination with other drugs, and has fulfilled all on-treatment requirements in the parent study.
Participant is currently benefiting from the treatment with alpelisib as determined by the Investigator in the parent study.
Participant demonstrated compliance with the visit schedule in the parent study, and in the opinion of the Investigator has shown willingness and ability to comply with future visit schedules, treatment plans, and any other study procedures in this protocol.
Participant had permanently discontinued from alpelisib in the parent study for any reason including withdrawal of consent.
Participant currently has ongoing/unresolved treatment related Grade 3 or higher AEs, and/or any ongoing/unresolved AE or toxicities for which alpelisib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have improved to allow alpelisib dosing to resume as stated in the parent protocol.
Participant's ongoing treatment is currently approved and reimbursed for their indication at their country level. In exceptional cases where the treatment is reimbursed at the country level, but not individual level, please contact the Novartis Study Team.
Concurrent participation in any other investigational clinical trial other than the parent study.
Single group
Alpelisib
DrugAdministered as oral tablets at dose levels as per the parent study, taken once daily.
Fulvestrant
DrugAdministered as an intramuscular injection at dose levels and dosing schedule as per standard of care, in accordance with the parent study.
Trastuzumab
DrugAdministered as an intravenous infusion of a reconstituted lyophilized powder at dose levels as per the parent study, given every 21 days.
Pertuzumab
DrugAdministered as an intravenous infusion of a solution concentrate at dose levels as per the parent study, given every 21 days.
Letrozole
DrugAdministered as oral tablets at a dose of 2.5 mg, taken once daily, as per the parent study.
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence of adverse events by type, frequency, and severity, as graded by the NCI CTCAE version 4.03.
Percentage of participants with Clinical Benefit Rate (CBR)
Clinical benefit is defined as the investigator's assessment that the participant continues to derive benefit from alpelisib treatment, based on overall clinical evaluation at scheduled visits, and that continued treatment is appropriate.
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This trial is not recruiting at the moment. You can still explore other options:
