Clinical trials: PIK3CA-Mutated Cancers
Lung Cancer, Breast Cancer
BKM120 in Cancers With PIK3CA Activating Mutations
In people whos cancers have a PIK3CA mutation, this trial will be evaluating the drug BKM120 as a possible treatment. BKM120 works by blocking the phosphatidylinositol-3-kinase (PI3K)pathway, thereby inhibiting tumor growth and…
- Conditions
- Lung Cancer, Breast Cancer, Colorectal Cancer, Cholangiocarcinoma
- Trial name
- NCT01501604
- Testing
- BKM120
- Sponsor
- Massachusetts General Hospital
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Anatomic Stage IV Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma
Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer
This phase Ib/II trial studies the side effects and best dose of copanlisib when given together with trastuzumab and pertuzumab and to see how well they work after induction treatment in treating patients with HER2 positive stage…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma, Metastatic Breast Carcinoma
- Trial name
- NCT04108858
- Testing
- Copanlisib, Pertuzumab, Trastuzumab
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer Stage IV
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
After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was…
- Trial name
- SAFIR 03 (NCT05625087)
- Testing
- Alpelisib, Ribociclib
- Where
- 44 sites in France
- Volunteers
- 4 people
- Sponsor
- UNICANCER
Solid Tumor
Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors
This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors . Everolimus 10 mg will be administered orally qd daily.
- Trial name
- NCT02449538
- Testing
- everolimus
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Samsung Medical Center
Breast Cancer
Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.
The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in…
- Trial name
- EPIK-B5 (NCT05038735)
- Testing
- Alpelisib, Fulvestrant
- Where
- 68 sites in Belgium, Bulgaria and 15 more
- Volunteers
- 210 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance…
- Trial name
- INAVO122 (NCT05894239)
- Testing
- Inavolisib, Phesgo, Taxane-based Chemotherapy
- Where
- 192 sites in United States, Argentina and 27 more
- Volunteers
- 230 people
- Sponsor
- Hoffmann-La Roche
Colon Cancer
Neoadjuvant Treatment of Colon Cancer
This study will investigate the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene the effect of preoperative combination chemotherapy in…
- Trial name
- NCT01108107
- Testing
- Oxaliplatin, Capecitabine, Panitumumab
- Where
- 3 sites in Denmark
- Volunteers
- 76 people
- Sponsor
- Vejle Hospital
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes
The purpose of this study is to test the good and bad effects of an experimental drug called SF1126. This drug is being tested in patients whose cancer has not been controlled by available standard therapies and who have certain…
- Trial name
- NCT02644122
- Testing
- SF1126
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Ezra Cohen
Lymphatic Malformations
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the change in radiological response and symptom severity upon treatment with alpelisib film-coated tablets (FCT) as compared to placebo.
- Trial name
- EPIK-L1 (NCT05948943)
- Testing
- Alpelisib
- Where
- 61 sites in United States, Argentina and 10 more
- Volunteers
- 232 people
- Sponsor
- Novartis Pharmaceuticals
Colon Cancer, Rectal Cancer
Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer
The purpose of this study is to test a new drug called MK-2206 for metastatic colorectal cancer. This drug is being tested in a subgroup of patients with colorectal cancer whose tumors have changes in certain genes that may make…
- Trial name
- NCT01186705
- Testing
- MK-2206
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
Biomarkers in Tissue Samples From Older Women With Breast Cancer
This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast cancer.
- Trial name
- NCT01346579
- Testing
- laboratory biomarker analysis
- Volunteers
- 505 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Metastatic Colorectal Cancer
Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status
This is a phase II trial to examine the efficacy of neratinib plus trastuzumab or neratinib plus cetuximab in patients with "quadruple wild-type" (all RAS/NRAS/BRAF/PIK3CA wild-type), metastatic colorectal cancer based on HER2…
- Trial name
- NCT03457896
- Testing
- Trastuzumab, Cetuximab, Neratinib
- Where
- 48 sites in United States
- Volunteers
- 35 people
- Sponsor
- NSABP Foundation Inc
Breast Cancers, PIK3CA Mutation-Related Tumors
Breast Cancer PET/CT Imaging With 68Ga-pAKTi
Abnormal activation of the PI3K-AKT signaling pathway in breast cancer patients is closely associated with tumor progression. Phosphorylated AKT (p-AKT) serves as a key indicator of pathway activation.
- Conditions
- Breast Cancers, PIK3CA Mutation-Related Tumors, PI3K Pathway Activated Tumors, PET / CT
- Trial name
- NCT06943313
- Testing
- 68Ga-pAKTi PET/CT probe
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Fudan University
Stomach Neoplasms Esophageal Neoplasms Metastatic Gastric Cancer Mutated PI3KCA Protein Overexpressed HER2 Protein
PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer
The study is intended to investigate the safety of BYL719 and AUY922 in patients with advanced gastric cancer, and to determine the MTD and/or RDE of both drugs in combination.
- Trial name
- NCT01613950
- Testing
- AUY922, BYL719
- Where
- 9 sites in United States, Germany and 4 more
- Volunteers
- 18 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumor, PIK3CA Mutation
Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations
This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib (an investigational PI3K inhibitor) when combined with an ISD and with or without nab-paclitaxel with a goal of reducing side…
- Conditions
- Advanced Solid Tumor, PIK3CA Mutation, PTEN Loss of Function Mutation
- Trial name
- NCT05300048
- Testing
- Serabelisib, Insulin Suppressing Diet, Nab paclitaxel
- Where
- 17 sites in United States
- Volunteers
- 34 people
- Sponsor
- Faeth Therapeutics
Breast Cancer
Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients
Men and post- or induced menopausal women with ER[+] and/or PgR[+], HER2[- ] advanced BC, with centrally-confirmed PI3KCAMut who progressed to an aromatase inhibitor (AI) regimen.
- Trial name
- METALLICA (NCT04300790)
- Testing
- Alpelisib, Metformin, Fulvestrant
- Where
- 19 sites in Spain
- Volunteers
- 69 people
- Sponsor
- MedSIR
Breast Neoplasms, Neoplasm Metastasis
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth…
- Trial name
- NCT07174336
- Testing
- LY4064809, Ribociclib, Palbociclib
- Where
- 364 sites in United States, Argentina and 17 more
- Volunteers
- 800 people
- Sponsor
- Eli Lilly and Company
Advanced Solid Tumors, Advanced Breast Cancer
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
- Trial name
- NCT06993844
- Testing
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
- Where
- 15 sites in United States, China
- Volunteers
- 233 people
- Sponsor
- Ensem Therapeutics
Neoplasm, Breast, Congenital, Familial and Genetic Disorders
SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)
The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulvestrant (either in first or…
- Trial name
- SEQUEL-Breast (NCT05392608)
- Testing
- Alpelisib 150 MG Oral Tablet [Piqray], Fulvestrant
- Where
- 25 sites in Netherlands
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Borstkanker Onderzoek Groep