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Showing 1–24 of 93 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: PIK3CA Clear all
Recruiting Phase 1 Interventional

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

NCT05216432
View directory record Official record
Conditions
PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor
Interventions
RLY-2608, Fulvestrant, Palbociclib 125mg, Ribociclib 400mg, Ribociclib 600mg, PF-07220060 100mg, PF-07220060 300 mg
Drug
Lead sponsor
Relay Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
930 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
24
States / cities
Tucson, Arizona • San Diego, California • Denver, Colorado + 17 more
Source: ClinicalTrials.gov public record
Updated Sep 21, 2025 · Synced Jul 21, 2026, 10:15 PM EDT
Terminated Phase 1 Interventional

Open-label Phase 1b Study of ARQ 092 in Combination With Anastrozole

NCT02476955
View directory record Official record
Conditions
Solid Tumors, Ovarian Cancer, Endometrial Cancer
Interventions
ARQ 092 + carboplatin + paclitaxel (Closed), ARQ 092 + paclitaxel (Closed), ARQ 092 + anastrozole
Drug
Lead sponsor
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Industry
Eligibility
18 Years and older · Female only
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
5
States / cities
Grand Rapids, Michigan • New York, New York • Oklahoma City, Oklahoma + 2 more
Source: ClinicalTrials.gov public record
Updated Sep 29, 2020 · Synced Jul 21, 2026, 10:15 PM EDT
Completed Phase 1 Interventional

PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer

NCT01613950
View directory record Official record
Conditions
Stomach Neoplasms Esophageal Neoplasms Metastatic Gastric Cancer Mutated PI3KCA Protein Overexpressed HER2 Protein
Interventions
AUY922, BYL719
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
2
States / cities
Boston, Massachusetts • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Dec 8, 2020 · Synced Jul 21, 2026, 10:15 PM EDT
Completed Phase 1 Interventional Results available

Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer

NCT01449370
View directory record Official record
Conditions
Metastatic Solid Tumors
Interventions
TAK-117
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
3
States / cities
Boston, Massachusetts • Detroit, Michigan • Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Mar 8, 2017 · Synced Jul 21, 2026, 10:15 PM EDT
Recruiting Phase 2 Interventional

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)

NCT06997588
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years to 100 Years
Enrollment
104 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
6
States / cities
St Louis, Missouri • Chapel Hill, North Carolina • Cincinnati, Ohio + 2 more
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Completed Phase 2 Interventional Results available

Akt Inhibitor MK2206 in Treating Patients With Previously Treated Colon or Rectal Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery

NCT01802320
View directory record Official record
Conditions
Colon Mucinous Adenocarcinoma, Colon Signet Ring Cell Adenocarcinoma, Rectal Mucinous Adenocarcinoma, Rectal Signet Ring Cell Adenocarcinoma, Recurrent Colon Carcinoma, Recurrent Rectal Carcinoma, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer
Interventions
Akt Inhibitor MK2206, Laboratory Biomarker Analysis, Pharmacological Study
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 19, 2019 · Synced Jul 21, 2026, 10:15 PM EDT
Recruiting Phase 1 Interventional

A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer

NCT05683418
View directory record Official record
Conditions
HR+/HER2-negative Breast Cancer
Interventions
TOS-358, Fulvestrant, Palbociclib, Ribociclib
Drug
Lead sponsor
Totus Medicines
Industry
Eligibility
18 Years and older · Female only
Enrollment
241 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
9
States / cities
Chicago, Illinois • Boston, Massachusetts • Las Vegas, Nevada + 4 more
Source: ClinicalTrials.gov public record
Updated Apr 21, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Terminated Phase 1 Interventional

Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma

NCT04431635
View directory record Official record
Conditions
Indolent Lymphoma
Interventions
Copanlisib, Nivolumab, Rituximab
Drug
Lead sponsor
University of Michigan Rogel Cancer Center
Other
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
5
States / cities
Chicago, Illinois • Ann Arbor, Michigan • Omaha, Nebraska + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 26, 2024 · Synced Jul 21, 2026, 10:15 PM EDT
Recruiting Phase 3 Interventional

A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

NCT07174336
View directory record Official record
Conditions
Breast Neoplasms, Neoplasm Metastasis
Interventions
LY4064809, Placebo, Ribociclib, Palbociclib, Abemaciclib, Anastrozole, Letrozole, Exemestane, Fulvestrant
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
920 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2033
U.S. locations
117
States / cities
Anchorage, Alaska • Chandler, Arizona • Phoenix, Arizona + 102 more
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Active, not recruiting Phase 2 Interventional

Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

NCT05090358
View directory record Official record
Conditions
Breast Cancer, Breast Cancer Stage IV, Metastatic Breast Cancer
Interventions
Ketogenic Diet, Low Carbohydrate Diet, Alpelisib, Fulvestrant, Canagliflozin
Dietary Supplement · Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
9
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 26, 2025 · Synced Jul 21, 2026, 10:15 PM EDT
Completed No phase listed Observational

Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study

NCT05294289
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum
Interventions
Alpelisib
Other
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
5 Years to 99 Years
Enrollment
77 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 23, 2025 · Synced Jul 21, 2026, 10:15 PM EDT
Completed Phase 1 Interventional

Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

NCT01226316
View directory record Official record
Conditions
Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, Tumour Response, Advanced or Metastatic Breast Cancer, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, PIK3CA, AKT1, PTEN, ER Positive, HER2 Positive
Interventions
AZD5363
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 130 Years
Enrollment
285 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2024
U.S. locations
12
States / cities
Los Angeles, California • Stanford, California • West Hollywood, California + 8 more
Source: ClinicalTrials.gov public record
Updated Jun 28, 2025 · Synced Jul 21, 2026, 10:15 PM EDT
Recruiting Phase 3 Interventional

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521
View directory record Official record
Conditions
PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
Interventions
RLY-2608, Capivasertib, Fulvestrant
Drug
Lead sponsor
Relay Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
540 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
52
States / cities
Gilbert, Arizona • Beverly Hills, California • Duarte, California + 42 more
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Completed Phase 1 Interventional

Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors

NCT04774952
View directory record Official record
Conditions
Solid Tumors
Interventions
RMC-5552
Drug
Lead sponsor
Revolution Medicines, Inc.
Industry
Eligibility
18 Years and older
Enrollment
58 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
8
States / cities
Irvine, California • Sacramento, California • San Francisco, California + 5 more
Source: ClinicalTrials.gov public record
Updated Apr 14, 2025 · Synced Jul 21, 2026, 10:15 PM EDT
Active, not recruiting Phase 2Phase 3 Interventional Results available

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

NCT04191499
View directory record Official record
Conditions
Breast Cancer
Interventions
Inavolisib, Placebo, Palbociclib, Fulvestrant
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
325 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
10
States / cities
Beverly Hills, California • Boston, Massachusetts • New York, New York + 7 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Active, not recruiting Phase 2 Interventional Results available

Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum

NCT04589650
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
0 Days to 100 Years
Enrollment
206 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2031
U.S. locations
11
States / cities
San Francisco, California • Aurora, Colorado • St Louis, Missouri + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Active, not recruiting Phase 2 Interventional

A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

NCT05154487
View directory record Official record
Conditions
Endometroid Endometrial Cancer
Interventions
Alpelisib Pill, Fulvestrant injection
Drug
Lead sponsor
GOG Foundation
Network
Eligibility
18 Years and older · Female only
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
18
States / cities
Duarte, California • Miami Beach, Florida • Orlando, Florida + 13 more
Source: ClinicalTrials.gov public record
Updated Mar 2, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Recruiting Phase 1 Interventional

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

NCT05307705
View directory record Official record
Conditions
Breast Cancer
Interventions
LOXO-783, Fulvestrant, Imlunestrant, Abemaciclib, Anastrozole, Exemestane, or Letrozole, Paclitaxel
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
260 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
17
States / cities
Scottsdale, Arizona • Los Angeles, California • San Francisco, California + 12 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Completed Phase 1Phase 2 Interventional Results available

MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)

NCT04495621
View directory record Official record
Conditions
Metastatic Colorectal Cancer
Interventions
MEN1611, Cetuximab
Drug
Lead sponsor
Menarini Group
Industry
Eligibility
18 Years and older
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
3
States / cities
Phoenix, Arizona • Anaheim, California • Tacoma, Washington
Source: ClinicalTrials.gov public record
Updated Apr 30, 2025 · Synced Jul 21, 2026, 10:15 PM EDT
Active, not recruiting Phase 2 Interventional

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)

NCT04980833
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years to 100 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 1, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Recruiting Phase 1 Interventional

Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors

NCT07524322
View directory record Official record
Conditions
Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation, HER2- Negative Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor, Hormone Receptor Positive Tumor, Cervical Cancer
Interventions
RGT-490
Drug
Lead sponsor
Regor Pharmaceuticals Inc.
Industry
Eligibility
18 Years and older
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
5
States / cities
Los Angeles, California • Houston, Texas • San Antonio, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Terminated Phase 1 Interventional Results available

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)

NCT02761694
View directory record Official record
Conditions
Cancer, Solid Tumors
Interventions
Vevorisertib, Fulvestrant, Paclitaxel
Drug
Lead sponsor
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Industry
Eligibility
18 Years and older
Enrollment
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2021
U.S. locations
6
States / cities
Las Vegas, Nevada • Oklahoma City, Oklahoma • Charleston, South Carolina + 3 more
Source: ClinicalTrials.gov public record
Updated May 5, 2023 · Synced Jul 21, 2026, 10:15 PM EDT
Active, not recruiting Phase 2 Interventional Results available

Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)

NCT04439175
View directory record Official record
Conditions
Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Multiple Myeloma
Interventions
Taselisib
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2027
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 5, 2026 · Synced Jul 21, 2026, 10:15 PM EDT
Completed Phase 2 Interventional Results available

Study of Sirolimus Therapy for Segmental Overgrowth Caused by Somatic PI3K Activation

NCT02428296
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum (PROS), Growth Disorder, Genetics
Interventions
Sirolimus
Drug
Lead sponsor
National Human Genome Research Institute (NHGRI)
NIH
Eligibility
3 Years to 65 Years
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Feb 4, 2020 · Synced Jul 21, 2026, 10:15 PM EDT