Clinical trial · Interventional
Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.
An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.
NCT07679269CI-TRIAL-00116503EPIK-ROnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation) | Breast Neoplasm | ONTOLOGY_EXACT | 0.85 |
| PIK3CA-Related Overgrowth Spectrum (PROS) | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpelisib | Drug | Alpelisib | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Alpelisib (BYL719) or in Combination Therapy
- description
- Eligible participants will continue treatment with the same combination and dose as in the parent study until end of treatment (EOT), followed by a 30-day safety follow-up.
- interventionNames
- Drug: Alpelisib
- Drug: Fulvestrant
- Drug: Trastuzumab
- Drug: Pertuzumab
- Drug: Letrozole
Primary outcomes (1)
- measure
- Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 53 months
- description
- Incidence of adverse events by type, frequency, and severity, as graded by the NCI CTCAE version 4.03.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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. * Pregnant or nursing (breastfeeding) women. * Female participants of childbearing potential who do not consent to use a highly effective method of contraception, and male participants who do not consent to use a condom and/or a highly effective method of contraception, including refraining from sperm donation and complying with measures to prevent exposure of a partner to alpelisib via seminal fluid, for the duration of the study and for one week following discontinuation of alpelisib (or longer if required per parent protocol). Other inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.