Clinical trials: PIK3CA Mutations
Breast Cancer
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). In preclinical studies, it demonstrated strong activity against PI3K p110α in vitro and in vivo, and inhibited tumor cell…
- Trial name
- NCT04631835
- Testing
- HS-10352
- Where
- 3 sites in China
- Volunteers
- 54 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Advanced Solid Malignancies, Breast Cancer - ER+, HER2 -
Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours
First time in patients study of AZD8835. The study has four parts. Part A AZD8835 is administered as a single agent in a multiple ascending dose escalation phase to investigate dose level for monotherapy.
- Conditions
- Advanced Solid Malignancies, Breast Cancer - ER+, HER2 -, Breast Cancer - ER+, HER2-, PIK3CA Gene Mutation
- Trial name
- NCT02260661
- Testing
- AZD8835, AZD8835 in combination with fulvestrant
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 20 people
- Sponsor
- AstraZeneca
Breast Neoplasms, Solid Tumors
A Phase 1/2a Study of K-1728 in Advanced Solid Tumors
This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors.
- Conditions
- Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation
- Trial name
- PIKYMA-01 (NCT07861932)
- Testing
- K-1728, Fulvestrant, Palbociclib
- Volunteers
- 110 people
- Sponsor
- KymaThera, Inc.
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
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
Endometrial Cancer
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer
This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.
- Trial name
- NCT06463028
- Testing
- Sapanisertib, Serabelisib, Paclitaxel
- Where
- 18 sites in United States
- Volunteers
- 40 people
- Sponsor
- Faeth Therapeutics
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
Non-Small Cell Lung Cancer
Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC
- Trial name
- NCT05054725
- Testing
- RMC-4630, Sotorasib
- Where
- 60 sites in United States, Australia and 8 more
- Volunteers
- 47 people
- Sponsor
- Revolution Medicines, Inc.
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)
This phase II MATCH treatment trial identifies the effects of copanlisib hydrochloride (copanlisib) in patients whose cancer has a genetic change called PIK3CA mutation.
- Conditions
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm, Refractory Lymphoma
- Trial name
- NCT05490771
- Testing
- Biopsy Procedure, Computed Tomography, Copanlisib Hydrochloride
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- National Cancer Institute (NCI)
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
Solid Tumors, Adult, PIK3CA Mutation-Related Tumors
Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma
This phase I/II trial tests the safety, side effects, and best dose of alpelisib and whether alpelisib and carboplatin work to shrink tumors in patients with solid tumors or human papillomavirus (HPV) positive squamous cell…
- Conditions
- Solid Tumors, Adult, PIK3CA Mutation-Related Tumors, PIK3CA Mutation, Human Papillomavirus-Related Carcinoma
- Trial name
- NCT05472220
- Testing
- Alpelisib, Carboplatin, Hyperpolarized Carbon-13 (13C) Pyruvate
- Sponsor
- Pamela Munster
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
Breast Cancer, Ovarian Cancer
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation
- Trial name
- NCT07524322
- Testing
- RGT-490
- Where
- 5 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.
Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma
Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer
This phase II trial studies how well copanlisib works in treating patients with endometrial cancer that has not decreased or disappeared, and the cancer may still be in the body despite treatment (persistent) or has come back…
- Conditions
- Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Undifferentiated Carcinoma
- Trial name
- NCT02728258
- Testing
- Copanlisib, Laboratory Biomarker Analysis
- Where
- 43 sites in United States
- Volunteers
- 11 people
- Sponsor
- NRG Oncology
Uterine Cancer
Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation
This is an open-label treatment program following basic prescribing information for patients with recurrent UPSC (Uterine Papillary Serous Carcinoma) to provide access to everolimus and limited treatment alternatives.
- Trial name
- NCT03285802
- Testing
- Letrozole, Everolimus
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Greater Baltimore Medical Center
Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation
A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations
Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways.
- Conditions
- Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation, Vascular Malformations, Venous Malformation
- Trial name
- TARGET-VM (NCT05983159)
- Testing
- Alpelisib, Mirdametinib
- Where
- 2 sites in Australia
- Volunteers
- 50 people
- Sponsor
- Murdoch Childrens Research Institute
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
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05216432
- Testing
- RLY-2608, Fulvestrant, Palbociclib 125mg
- Where
- 37 sites in United States, Australia and 3 more
- Volunteers
- 930 people
- Sponsor
- Relay Therapeutics, Inc.
Cancer, Solid Tumors
Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001)
The primary objectives of this study are: Part 1 - Vevorisertib as single agent: To assess the safety and tolerability of vevorisertib in participants with advanced solid tumors with v-Akt murine thymoma viral oncogene homolog…
- Trial name
- NCT02761694
- Testing
- Vevorisertib, Fulvestrant, Paclitaxel
- Where
- 6 sites in United States
- Volunteers
- 78 people
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Breast Cancer
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
This study was designed to assess the safety and efficacy of the combination of dapagliflozin plus metformin extended release (XR) compared with metformin XR during treatment with alpelisib plus fulvestrant in participants with…
- Trial name
- EPIK-B4 (NCT04899349)
- Testing
- Alpelisib, Fulvestrant, Metformin XR
- Where
- 2 sites in United States, Malaysia
- Volunteers
- 2 people
- Sponsor
- Novartis Pharmaceuticals