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
Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma
Akt Inhibitor MK2206 in Treating Patients With Recurrent or Advanced Endometrial Cancer
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with recurrent or advanced endometrial cancer.
- Conditions
- Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma
- Trial name
- NCT01307631
- Testing
- Akt Inhibitor MK2206, Laboratory Biomarker Analysis
- Where
- 7 sites in United States
- Volunteers
- 37 people
- Sponsor
- National Cancer Institute (NCI)
Colon Mucinous Adenocarcinoma, Colon Signet Ring Cell Adenocarcinoma
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
This phase II trial studies how well v-akt murine thymoma viral oncogene homolog 1 (Akt) inhibitor MK2206 works in treating patients with previously treated colon or rectal cancer that has spread from the primary site to other…
- Conditions
- Colon Mucinous Adenocarcinoma, Colon Signet Ring Cell Adenocarcinoma, Rectal Mucinous Adenocarcinoma, Rectal Signet Ring Cell Adenocarcinoma
- Trial name
- NCT01802320
- Testing
- Akt Inhibitor MK2206, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- National Cancer Institute (NCI)
PIK3CA Mutated Advanced Solid Tumors, PIK3CA Amplified Advanced Solid Tumors
A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab)…
- Trial name
- NCT01708161
- Testing
- BYL719, AMG 479
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 47 people
- Sponsor
- Novartis Pharmaceuticals
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)
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
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)
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
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
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
This phase II MATCH treatment trial identifies the effects of GDC-0032 (taselisib) in patients whose cancer has a genetic change called PIK3CA mutation.
- Conditions
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma
- Trial name
- NCT04439175
- Testing
- Taselisib
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- National Cancer Institute (NCI)
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)
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
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
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
Breast Cancer
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals