Clinical trials: PIK3CA Mutations
Advanced or Metastatic Breast Cancer, ER+ve Advanced or Metastatic Breast Cancer
Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients
The purpose of this study is to investigate the safety and efficacy of different doses and schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with advanced or metastatic breast cancer.
- Trial name
- BEECH (NCT01625286)
- Testing
- AZD5363 when combined with weekly paclitaxel., AZD5363when combined with weekly paclitaxel.
- Where
- 41 sites in Bulgaria, Canada and 9 more
- Volunteers
- 148 people
- Sponsor
- AstraZeneca
PIK3CA-related Overgrowth Spectrum (PROS)
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 Phase II, multicenter, open-label study, preceded by a retrospective non-interventional period, is assessing the long-term safety and efficacy of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth…
- Trial name
- EPIK-P3 (NCT04980833)
- Testing
- Alpelisib
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
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
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
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
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
PIK3CA-Related Overgrowth Spectrum (PROS), Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation)
Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.
The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs.
- Trial name
- EPIK-RO (NCT07679269)
- Testing
- Alpelisib, Fulvestrant, Trastuzumab
- Volunteers
- 51 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumors With an Alteration of the PIK3CA Gene, Estrogen Receptor Positive Breast Cancer
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for…
- Trial name
- NCT01219699
- Testing
- BYL719, Fulvestrant
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 221 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Endometrial Cancer
A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors
This study aims to test the hypothesis that combining serabelisib, a PI3K alpha isoform inhibitor, with an SGLT2 inhibitor, canagliflozin will improve efficacy in the treatment of patients with advanced solid tumors.
- Conditions
- Breast Cancer, Endometrial Cancer, Lung Cancer, Colo-rectal Cancer
- Trial name
- NCT04073680
- Testing
- Serabelisib, Canagliflozin 300mg
- Volunteers
- 60 people
- Sponsor
- Petra Pharma
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
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
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.
PIK3CA Mutations, Advanced Solid Tumors, Adult
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of…
- Conditions
- PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer
- Trial name
- NCT07383506
- Testing
- CGT6297
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- Cogent Biosciences, Inc.
PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations
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)
This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (RLY-2608), in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations…
- Conditions
- PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations, Vascular Malformations, PIK3CA Mutation
- Trial name
- NCT06789913
- Testing
- RLY-2608
- Where
- 40 sites in United States, Australia and 7 more
- Volunteers
- 277 people
- Sponsor
- Relay Therapeutics, Inc.
Advanced Solid Malignancy, Safety and Tolerability
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future.
- Conditions
- Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT01226316
- Testing
- AZD5363
- Where
- 34 sites in United States, Canada and 8 more
- Volunteers
- 285 people
- Sponsor
- AstraZeneca
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies.
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07897721
- Testing
- PF-08165784, Fulvestrant, Atirmociclib
- Volunteers
- 268 people
- Sponsor
- Pfizer
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
- 363 sites in United States, Argentina and 17 more
- Volunteers
- 800 people
- Sponsor
- Eli Lilly and Company
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, Colorectal Cancer
Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors
This is a first-in-human Phase 1a/1b, multicenter, open-label, dose-escalation, dose and schedule optimization, and expansion study of TPST-1495 as a single agent and in combination with pembrolizumab to determine its maximum…
- Conditions
- Solid Tumor, Colorectal Cancer, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT04344795
- Testing
- TPST-1495 twice daily, TPST-1495 once daily or on intermittent schedule, Pembrolizumab
- Where
- 11 sites in United States
- Volunteers
- 89 people
- Sponsor
- Tempest Therapeutics
HR+/HER2-negative Breast Cancer, Metastatic Breast Cancer
Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer
This is a Phase 1b/2, open-label, parallel-arms pilot study in men and post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a…
- Trial name
- Amelia-1 (NCT05455619)
- Testing
- Evexomostat
- Where
- 10 sites in United States
- Volunteers
- 52 people
- Sponsor
- SynDevRx, Inc.
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
PIK3CA Mutation-Related Tumors
A Study of WX390 in Patients With Advanced Solid Tumors With PIK3CA Mutations
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 in patients with advanced solid tumors. The main question it aims to answer is: safety and preliminary efficacy in WX390 therapy.
- Trial name
- NCT06132932
- Testing
- WX390
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd