PIK3CA-Related Overgrowth Spectrum (PROS)NCT04085653
Managed Access Programs for BYL719, Alpelisib
A study testing alpelisib in people with PIK3CA-Related Overgrowth Spectrum (PROS) and Breast Cancer, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this registration is to list Managed Access Programs (MAPs) related to BYL719, Alpelisib Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- PIK3CA-Related Overgrowth Spectrum (PROS), Breast Cancer
- What is being tested?
- alpelisib
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
- The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
- Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
- Managed Access provision is allowed per local laws/regulations.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs contact
Novartis Pharmaceuticals contact
About this study
The purpose of this registration is to list Managed Access Programs (MAPs) related to BYL719, Alpelisib
Read the detailed description
CBYL719F12001M - Available - Managed Access Program (MAP) Cohort to provide access to Alpelisib (BYL719) for patients with PIK3CA-Related Overgrowth Spectrum (PROS)
CBYL719C2001M - Available - Managed Access Program (MAP) Cohort to provide access to alpelisib (BYL719) for patients with HR-positive, HER2-negative advanced breast cancer with mutated phosphoinositide 3-kinase who progressed on or after AI treatment
- Being tested
- alpelisib
- Keywords
- BYL719, alpelisib, MAP
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpelisibDrug
Also called BYL719
Patients receive alpelisib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PIK3CA-Related Overgrowth Spectrum (PROS)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085653
- Sponsor's protocol ID
- CBYL719F12001M
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2019
- Last updated
- 14 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managed Access Programs for BYL719, Alpelisib
- ClinicalTrials.gov ID
- NCT04085653
- Acronym / sponsor ID
- CBYL719F12001M
- Keywords
- BYL719, alpelisib, MAP
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registration is to list Managed Access Programs (MAPs) related to BYL719, Alpelisib
Detailed description
CBYL719F12001M - Available - Managed Access Program (MAP) Cohort to provide access to Alpelisib (BYL719) for patients with PIK3CA-Related Overgrowth Spectrum (PROS)
CBYL719C2001M - Available - Managed Access Program (MAP) Cohort to provide access to alpelisib (BYL719) for patients with HR-positive, HER2-negative advanced breast cancer with mutated phosphoinositide 3-kinase who progressed on or after AI treatment
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
- The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
- Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alpelisibAlso: BYL719Patients receive alpelisib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Related trials for PIK3CA-Related Overgrowth Spectrum (PROS)
Active, not recruitingPhase 2
Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)
PIK3CA-related Overgrowth Spectrum (PROS)
RecruitingPhase 2
EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
PIK3CA-related Overgrowth Spectrum (PROS)
Active, not recruitingPhase 2
Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum
PIK3CA-related Overgrowth Spectrum (PROS)
Not yet recruitingPhase 2
Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.
PIK3CA-Related Overgrowth Spectrum (PROS), Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation)
RecruitingPhase 2
A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)
PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs contact
Novartis Pharmaceuticals contact
Questions about this trial
What is this clinical trial studying?
A study testing alpelisib in people with PIK3CA-Related Overgrowth Spectrum (PROS) and Breast Cancer, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.