- RecruitingPHASE2
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)
This study looks at how well a medicine called alpelisib works for children and adults with a condition called PROS, which causes parts of the body to grow too much. It also checks if the medicine is safe and how it moves through the body.
For: PIK3CA-related Overgrowth Spectrum (PROS)United States · Australia · Austria - Active not recruitingPHASE1, PHASE2
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
This study is testing a new drug called elacestrant with other breast cancer medicines. It's for people with a specific type of advanced breast cancer that has spread. The main goals are to see if these drug combinations are safe and if they can help shrink the cancer.
For: Breast Cancer · Metastatic Breast CancerUnited States · Argentina · Australia - RecruitingPHASE3
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
This study looks at two drug combinations, inavolisib with fulvestrant, and alpelisib with fulvestrant, for advanced breast cancer that has specific genetic changes and has already been treated with certain therapies. It aims to see which combination works better and is safer.
For: Breast CancerUnited States · Argentina · Australia - RecruitingPHASE2, PHASE3
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
This study is testing a new medicine, alpelisib, for children and adults with lymphatic malformations caused by a specific gene change (PIK3CA mutation). It will compare alpelisib to a dummy medicine to see if it can shrink the malformations and reduce symptoms.
For: Lymphatic MalformationsUnited States · Argentina · Australia - Active not recruitingPHASE2
Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum
This study is testing a new medicine, Alpelisib, for children and adults with a condition called PIK3CA-related overgrowth spectrum (PROS). Researchers want to see if it's safe and effective in helping manage the overgrowth caused by this condition.
For: PIK3CA-related Overgrowth Spectrum (PROS)United States · Canada · China - Active not recruitingPHASE3
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)
This study looks at new drug combinations for advanced breast cancer that has grown despite previous treatments. It compares different medications, including gedatolisib, fulvestrant, and palbociclib, to see if they are safe and effective.
For: Breast CancerUnited States · Argentina · Australia - Active not recruitingPHASE2
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)
This study looks at how safe and effective Alpelisib is for children and adults with PROS (a growth condition) over a long time. It includes people who were in a previous study and explores if the medication helps them.
For: PIK3CA-related Overgrowth Spectrum (PROS)United States · France · Ireland - Active not recruitingPHASE2
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
This study looks at a new way to pick the best treatment for advanced breast cancer by checking special bits of cancer DNA in the blood. It compares two drugs, alpelisib and ribociclib, when given with fulvestrant, to see which works better for certain patients.
For: Breast Cancer Stage IVFrance