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.
Eligible participants are those who are receiving alpelisib, either as a single agent or in combination with other drugs, at the end of one of the following parent studies: CBYL719F12401 (NCT04980833), CBYL719G12301 (NCT04208178), CBYL719C2303 (NCT05038735), CBYL719C1201 (NCT04524000), CBYL719C2201 (NCT04544189), or CLEE011X2107 (NCT01872260). Participants transition directly from the parent study into this roll-over study without a separate screening period. At enrollment, participants continue treatment with the same combination and the same dose that were administered at the end of the parent study. Study visits, treatment administration, and safety assessments generally follow the schedules used in the parent study. Participants continue receiving alpelisib until clinical benefit is no longer observed, study treatment is discontinued for safety or other protocol-defined reasons, or another discontinuation criterion is met. Clinical benefit is evaluated by the investigator at scheduled visits. Safety is monitored throughout the study through the collection of adverse events and serious adverse events. Safety assessments are conducted at regular intervals during treatment in accordance with the study protocol and local clinical practice. At discontinuation of study treatment, participants complete an end-of-treatment visit. All participants are followed for safety for 30 days after the last dose of alpelisib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Administered as oral tablets at dose levels as per the parent study, taken once daily.
Administered as an intramuscular injection at dose levels and dosing schedule as per standard of care, in accordance with the parent study.
Administered as an intravenous infusion of a reconstituted lyophilized powder at dose levels as per the parent study, given every 21 days.
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.
Time frame: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 53 months
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.
Time frame: Up to approximately 54 months
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Administered as an intravenous infusion of a solution concentrate at dose levels as per the parent study, given every 21 days.
Administered as oral tablets at a dose of 2.5 mg, taken once daily, as per the parent study.