Clinical trials: PIK3CA Gene Mutation
Advanced HER2+Breast Cancer
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
The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab…
- Trial name
- EPIK-B2 (NCT04208178)
- Testing
- Alpelisib, Trastuzumab, Pertuzumab
- Where
- 11 sites in United States, Belgium and 5 more
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Gastric Cancer
Study of AZD5363 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring PIK3CA Mutation and/or PIK3CA Amplification as a Second-line Chemotherapy
This study is a single arm, single center phase II study of AZD5363 in combination with paclitaxel in patients with advanced gastric adenocarcinoma harboring PIK3CA mutation or amplification as a second line chemotherapy.
- Trial name
- NCT02451956
- Testing
- AZD5363, paclitaxel
- Where
- South Korea
- Volunteers
- 21 people
- Sponsor
- Samsung Medical Center
Advanced Cancer, Breast Cancer
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination…
- Conditions
- Advanced Cancer, Breast Cancer, Advanced Solid Tumors, PI3K Gene Mutation
- Trial name
- PIKture-01 (NCT06239467)
- Testing
- OKI-219, Fulvestrant, Trastuzumab
- Where
- 33 sites in United States, Belgium and 4 more
- Volunteers
- 200 people
- Sponsor
- OnKure, Inc.
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
Advanced Breast Cancer
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
The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.
- Trial name
- TELEPIK (NCT04862143)
- Testing
- Alpelisib, Fulvestrant, Goserelin
- Where
- Sweden
- Volunteers
- 2 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10352 plus…
- Trial name
- NCT05504213
- Testing
- HS-10352 combined with fulvestrant (Stage 1), HS-10352 combined with fulvestrant (Stage 2)
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Breast Cancer
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as…
- Trial name
- PIKASSO-01 (NCT05307705)
- Testing
- LOXO-783, Fulvestrant, Imlunestrant
- Where
- 50 sites in United States, Australia and 10 more
- Volunteers
- 260 people
- Sponsor
- Eli Lilly and Company
Recurrent Breast Carcinoma, Stage IIIB Breast Cancer
Akt Inhibitor MK2206 in Treating Patients With Advanced Breast Cancer
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with breast cancer cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment.
- Conditions
- Recurrent Breast Carcinoma, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Trial name
- NCT01277757
- Testing
- Akt Inhibitor MK2206, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- National Cancer Institute (NCI)
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05759949
- Testing
- RLY-5836, Fulvestrant, Palbociclib
- Where
- 7 sites in United States
- Volunteers
- 41 people
- Sponsor
- Relay Therapeutics, Inc.
TNBC - Triple-Negative Breast Cancer, TNBC
A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation
This is an open-label, Simon's optimal two-stage design, single-arm, Phase II study with first 6 patients in the safety run-in portion.
- Trial name
- NCT07441512
- Testing
- Inavolisib in Combination With Eribulin
- Volunteers
- 26 people
- Sponsor
- Hu Hai
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
Triple Negative Breast Neoplasms
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
The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA…
- Trial name
- EPIK-B3 (NCT04251533)
- Testing
- alpelisib, nab-paclitaxel
- Where
- 78 sites in United States, Argentina and 28 more
- Volunteers
- 137 people
- Sponsor
- Novartis Pharmaceuticals
HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
A Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
This is a open-label, multicenter phase Ib study to evaluate safety and efficacy of TQ-B3525 tablets combined with fulvestrant injection in subjects with HR-positive, HER2-negative and PIK3CA mutation advanced breast cancer.
- Trial name
- NCT04355520
- Testing
- TQ-B3525, Fulvestrant injection
- Where
- 4 sites in China
- Volunteers
- 42 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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 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
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