Alpelisib
Information
- Drug Name
- Alpelisib
- Description
- Entry(CIViC)
- 13
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| head and neck cancer |
PIK3CA p.His1047Arg (p.H1047R) ( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.His1047Arg (p.H1047R) ( ENST00000263967.4, ENST00000643187.1 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 1 | 25550549 | Detail |
| cancer | PIK3CA MUTATION PIK3CA MUTATION | D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 24608574 | Detail |
| stomach carcinoma |
PIK3CA AMPLIFICATION ( ENST00000263967.4, ENST00000497599.5 ) PIK3CA AMPLIFICATION ( ENST00000263967.4 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 24608574 | Detail |
| prostate cancer | PTEN MUTATION PTEN MUTATION | D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 25544636 | Detail |
| breast cancer | RB1 PHOSPHORYLATION RB1 PHOSPHORYLATION | B |
Predictive
|
Supports
|
Resistance |
N/A
|
3 | 25002028 | Detail |
| breast cancer |
SGK1 OVEREXPRESSION ( ENST00000367858.10 ) SGK1 OVEREXPRESSION ( ENST00000367858.10 ) |
D |
Predictive
|
Supports
|
Resistance | Somatic | 5 | 27451907 | Detail |
| breast cancer |
SGK1 OVEREXPRESSION ( ENST00000367858.10 ) SGK1 OVEREXPRESSION ( ENST00000367858.10 ) |
B |
Predictive
|
Supports
|
Resistance | Somatic | 3 | 27451907 | Detail |
| breast cancer |
SGK1 OVEREXPRESSION ( ENST00000367858.10 ) SGK1 OVEREXPRESSION ( ENST00000367858.10 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 27451907 | Detail |
| estrogen-receptor positive breast cancer | CDK4 EXPRESSION CDK4 EXPRESSION | D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 25002028 | Detail |
| colorectal cancer | BRAF V600 BRAF V600 | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 28363909 | Detail |
| breast cancer |
PTEN DELETION ( ENST00000371953.8 ) PTEN DELETION ( ENST00000371953.8 ) |
D |
Predictive
|
Supports
|
Resistance | Somatic | 4 | 25409150 | Detail |
| breast cancer | PIK3CA MUTATION PIK3CA MUTATION | A |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 5 | 31091374 | Detail |
| breast cancer |
PIK3CA p.Glu542Lys (p.E542K) ( ENST00000643187.1, ENST00000263967.4 ) PIK3CA p.Glu542Lys (p.E542K) ( ENST00000263967.4, ENST00000643187.1 ) |
A |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 31091374 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In a panel of head and neck cancer cell lines, 2 l... | PIK3CA |
PIK3CA p.His1047Arg (p.H1047R) ( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.His1047Arg (p.H1047R) ( ENST00000263967.4, ENST00000643187.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| A set of 474 cell lines from the Cancer Cell Line ... | PIK3CA | PIK3CA MUTATION PIK3CA MUTATION | Sensitivity | true | CIViC Evidence | detail |
| 474 cancer cell lines from the cancer cell line en... | PIK3CA |
PIK3CA AMPLIFICATION ( ENST00000263967.4, ENST00000497599.5 ) PIK3CA AMPLIFICATION ( ENST00000263967.4 ) |
Sensitivity | true | CIViC Evidence | detail |
| Castrated mice bearing androgen-sensitive human pr... | PTEN | PTEN MUTATION PTEN MUTATION | Sensitivity | true | CIViC Evidence | detail |
| The p110alpha-specific PI3K inhibitor BYL719 (Alpe... | RB1 | RB1 PHOSPHORYLATION RB1 PHOSPHORYLATION | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| SGK1 mRNA expression was elevated in five breast c... | SGK1 |
SGK1 OVEREXPRESSION ( ENST00000367858.10 ) SGK1 OVEREXPRESSION ( ENST00000367858.10 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| A group of 18 breast cancer patients were treated ... | SGK1 |
SGK1 OVEREXPRESSION ( ENST00000367858.10 ) SGK1 OVEREXPRESSION ( ENST00000367858.10 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| The alpelisib (PI3Kalpha inhibitor) resistant brea... | SGK1 |
SGK1 OVEREXPRESSION ( ENST00000367858.10 ) SGK1 OVEREXPRESSION ( ENST00000367858.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| In mouse xenograft studies of PIK3CA mutant breast... | CDK4 | CDK4 EXPRESSION CDK4 EXPRESSION | Sensitivity | true | CIViC Evidence | detail |
| In a Phase Ib Dose-Escalation Study of Encorafenib... | BRAF | BRAF V600 BRAF V600 | Sensitivity | true | CIViC Evidence | detail |
| A case report described a responder to PI3K inhibi... | PTEN |
PTEN DELETION ( ENST00000371953.8 ) PTEN DELETION ( ENST00000371953.8 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In a phase 3 trial, patients with hormone receptor... | PIK3CA | PIK3CA MUTATION PIK3CA MUTATION | Sensitivity | true | CIViC Evidence | detail |
| In a phase 3 trial, 572 patients with hormone rece... | PIK3CA |
PIK3CA p.Glu542Lys (p.E542K) ( ENST00000643187.1, ENST00000263967.4 ) PIK3CA p.Glu542Lys (p.E542K) ( ENST00000263967.4, ENST00000643187.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT04188548 | Active, not recruiting | Phase 1 | A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer | December 10, 2019 | December 2027 |
| NCT04208178 | Active, not recruiting | Phase 3 | Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation | July 16, 2020 | September 16, 2024 |
| NCT04216472 | Active, not recruiting | Phase 2 | Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations | February 5, 2020 | December 31, 2025 |
| NCT04251533 | Active, not recruiting | Phase 3 | Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss | June 8, 2020 | September 2, 2024 |
| NCT04729387 | Active, not recruiting | Phase 3 | Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected | July 2, 2021 | January 31, 2026 |
| NCT04300790 | Active, not recruiting | Phase 2 | Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients | October 23, 2020 | June 30, 2026 |
| NCT03056755 | Active, not recruiting | Phase 2 | Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments | August 14, 2017 | July 17, 2025 |
| NCT04591431 | Active, not recruiting | Phase 2 | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy | October 7, 2020 | June 2025 |
| NCT03284957 | Active, not recruiting | Phase 1/Phase 2 | Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer | September 20, 2017 | December 29, 2027 |
| NCT04544189 | Active, not recruiting | Phase 2 | Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer | January 20, 2021 | February 28, 2025 |
| NCT04980833 | Active, not recruiting | Phase 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) | January 27, 2022 | September 1, 2027 |
| NCT05090358 | Active, not recruiting | Phase 2 | Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer | October 8, 2021 | October 8, 2024 |
| NCT05063786 | Active, not recruiting | Phase 3 | Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) | September 14, 2021 | November 2024 |
| NCT04524000 | Active, not recruiting | Phase 2 | Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer | November 20, 2020 | January 31, 2025 |
| NCT04473040 | Available | Managed Access Program to Provide Access to Alpelisib for Patients With Advanced Breast Cancer | |||
| NCT04085653 | Available | Managed Access Program (MAP) to Provide Access to Alpelisib (BYL719) for Patients With PIK3CA-Related Overgrowth Spectrum (PROS) | |||
| NCT01923168 | Completed | Phase 2 | Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women | March 11, 2014 | July 8, 2017 |
| NCT02624557 | Completed | Phase 1 | Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment. | December 21, 2015 | October 1, 2017 |
| NCT02077933 | Completed | Phase 1 | Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors | May 14, 2014 | April 12, 2019 |
| NCT03207529 | Completed | Phase 1 | Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer | June 7, 2019 | December 31, 2023 |
| NCT03439046 | Completed | Phase 3 | Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant | February 2, 2018 | December 11, 2023 |
| NCT04285723 | Completed | Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib | June 9, 2020 | April 16, 2021 | |
| NCT02437318 | Completed | Phase 3 | Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. | July 23, 2015 | June 9, 2023 |
| NCT03706573 | No longer available | Managed Access Program to Provide Alpelisib for Patients With HR+ Advanced or Metastatic Breast Cancer | |||
| NCT03941782 | No longer available | Compassionate Use of BYL 719 Alpelisib | |||
| NCT05983159 | Not yet recruiting | Phase 2 | A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations | August 2024 | December 2026 |
| NCT06083038 | Recruiting | Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib | October 5, 2023 | June 1, 2025 | |
| NCT02925234 | Recruiting | Phase 2 | The Drug Rediscovery Protocol (DRUP Trial) | August 2016 | December 2027 |
| NCT04526470 | Recruiting | Phase 1/Phase 2 | Alpelisib and Paclitaxel in PIK3CA-altered Gastric Cancer | September 1, 2020 | December 2024 |
| NCT04589650 | Recruiting | Phase 2 | Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum | April 19, 2021 | March 11, 2031 |
| NCT04762979 | Recruiting | Phase 2 | Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer | February 12, 2021 | January 2025 |
| NCT05230810 | Recruiting | Phase 1/Phase 2 | Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. | August 25, 2022 | June 30, 2025 |
| NCT05294289 | Recruiting | Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study | May 16, 2022 | June 28, 2024 | |
| NCT05501886 | Recruiting | Phase 3 | Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) | September 30, 2022 | September 30, 2026 |
| NCT05508906 | Recruiting | Phase 1 | Phase 1b Combo w/ Ribociclib and Alpelisib | August 31, 2022 | August 31, 2024 |
| NCT05563220 | Recruiting | Phase 1/Phase 2 | Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer | January 24, 2023 | August 31, 2026 |
| NCT05564377 | Recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial | April 7, 2023 | July 1, 2030 |
| NCT05625087 | Recruiting | Phase 2 | Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib | October 19, 2023 | June 2030 |
| NCT05631795 | Recruiting | Phase 4 | Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment | August 9, 2022 | November 3, 2025 |
| NCT05646862 | Recruiting | Phase 3 | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | June 7, 2023 | March 30, 2029 |
| NCT05933395 | Recruiting | Phase 2 | Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor | October 10, 2023 | October 2031 |
| NCT05948943 | Recruiting | Phase 2/Phase 3 | Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation. | November 24, 2023 | January 3, 2030 |
| NCT04967248 | Recruiting | A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting | June 21, 2023 | December 19, 2025 | |
| NCT04997902 | Recruiting | Phase 1/Phase 2 | Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) | December 7, 2021 | September 2024 |
| NCT05038735 | Recruiting | Phase 3 | Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | November 29, 2021 | August 23, 2027 |
| NCT05101564 | Recruiting | Phase 2 | Umbrella Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer | March 20, 2023 | December 2026 |
| NCT05143229 | Recruiting | Phase 1 | Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer | March 28, 2022 | December 2025 |
| NCT03601507 | Terminated | Phase 2 | Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer | March 11, 2019 | May 24, 2022 |
| NCT04899349 | Terminated | Phase 2 | Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant | April 6, 2022 | May 10, 2023 |
| NCT04862143 | Terminated | Phase 2 | Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant | March 8, 2022 | September 19, 2022 |
| NCT02620839 | Terminated | Phase 1 | Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies | December 1, 2016 | January 28, 2019 |
| NCT03386162 | Terminated | Phase 2 | SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer | March 15, 2018 | November 18, 2022 |
| NCT04801966 | Terminated | N/A | Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study | September 23, 2021 | December 30, 2022 |
| NCT04852081 | Unknown status | Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study. | January 1, 2021 | December 1, 2021 | |
| NCT03631953 | Unknown status | Phase 1 | Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas | September 30, 2019 | September 1, 2022 |
| NCT05967286 | Withdrawn | Phase 2 | Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial | October 23, 2023 | April 30, 2025 |
| NCT05238831 | Withdrawn | Early Phase 1 | SMMART Adaptive Clinical Treatment (ACT) Trial | January 30, 2023 | May 31, 2026 |
| NCT05472220 | Withdrawn | Phase 1 | Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma | November 1, 2022 | April 30, 2028 |
- Target (Drug list of Screening Committee of Anticancer Drugs)
- Phosphoinositide 3-kinase (PI3K)
- Synonym (Drug list of Screening Committee of Anticancer Drugs)
- BYL719