Clinical trials: PI3K Pathway Activated Tumors
Low Grade Glioma, World Health Organization (WHO) Grade II Astrocytomas
Everolimus With and Without Temozolomide in Adult Low Grade Glioma
The purpose of this study is to find out what effects, good and/or bad, everolimus (RAD001, also known as Afinitor®) alone or with temozolomide has on the patient and the patient's low-grade glioma.
- Conditions
- Low Grade Glioma, World Health Organization (WHO) Grade II Astrocytomas, Oligodendrogliomas, Mixed Oligoastrocytomas
- Trial name
- NCT02023905
- Testing
- Everolimus, Temozolomide
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of California, San Francisco
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumors, Lung Cancer
A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies
This study will assess the safety of combining two agents (everolimus and BKM120) for the treatment of advanced cancer arising from solid organ in patients who are no longer benefiting from or unable to withstand standard…
- Trial name
- NCT01470209
- Testing
- BKM120, Everolimus
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Emory University
Breast Cancer - ER+, HER2-, PIK3CA Gene Mutation
PI3K Pathway Activation Markers in ER-Positive, HER2-Negative Breast Cancer: A Clinicopathologic Study
The goal of this observational study is to examine whether markers of PI3K pathway activation are associated with endocrine therapy response and clinicopathologic features in estrogen receptor-positive, HER2-negative breast…
- Trial name
- p-AKT p-S6 (NCT07387861)
- Testing
- Not applicable- observational study
- Volunteers
- 70 people
- Sponsor
- Assiut University
PI3K Pathway Activated Tumors
BKM120 for Patients With PI3K-activated Tumors
The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
- Trial name
- SIGNATURE (NCT01833169)
- Testing
- BKM120
- Where
- 59 sites in United States
- Volunteers
- 146 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway
This is a multi-center,randomized,phase 3 clinical trial. In the study, HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway after progression on trastuzumab are enrolled and…
- Trial name
- NCT04736589
- Testing
- Inetetamab, Rapamycin, Pyrotinib
- Where
- China
- Volunteers
- 270 people
- Sponsor
- Peking Union Medical College
Glioblastoma
Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma
BKM120 is a newly discovered drug that has been used in other research studies. Information from those other research studies suggests that BKM120 may help to slow or stop the growth of malignant gliomas.
- Trial name
- NCT01339052
- Testing
- BKM120, Surgery
- Where
- 7 sites in United States
- Volunteers
- 65 people
- Sponsor
- L. Nicolas Gonzalez Castro, MD, PhD
Metastatic Breast Cancer
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2…
- Trial name
- NCT01288092
- Testing
- BEZ235
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.
- Trial name
- BELLE-4 (NCT01572727)
- Testing
- Paclitaxel, BKM120
- Where
- 112 sites in United States, Australia and 20 more
- Volunteers
- 416 people
- Sponsor
- Novartis Pharmaceuticals
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
Non-small Cell Lung Cancer
Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that…
- Trial name
- BASALT-1 (NCT01297491)
- Testing
- BKM120
- Where
- 92 sites in United States, Argentina and 16 more
- Volunteers
- 63 people
- Sponsor
- Novartis Pharmaceuticals