Clinical trials: PI3K Pathway Inhibition
Prostate Cancer
Hyperpolarized C-13 Pyruvate as a Biomarker in Patients With Advanced Solid Tumor Malignancies
This is a single center prospective imaging study investigating the utility of hyperpolarized C-13 pyruvate as a Biomarker of PI3K/mTOR pathway inhibition in patients with advanced solid tumor malignancies.
- Trial name
- NCT02913131
- Testing
- Pyruvate (13C), MRI
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Rahul Aggarwal
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
Solid Tumor
First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies
This is a Phase 1, first-in-human, open-label, non-randomized, dose escalation, trial to explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity signals of MSC2363318A.
- Trial name
- NCT01971515
- Testing
- MSC2363318A, MSC2363318A plus Trastuzumab, MSC2363318A plus Tamoxifen
- Where
- 15 sites in United States
- Volunteers
- 101 people
- Sponsor
- EMD Serono
Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome, Acute Myeloid Leukemia, in Relapse
PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) (LAM-PIK)
Phase II open-label single-arm prospective multicentric clinical trial of PF-05212384 (PKI-587) delivered by intravenous route. A 2-stage Fleming design will be employed.
- Conditions
- Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome, Acute Myeloid Leukemia, in Relapse, de Novo Acute Myeloid Leukemia at Diagnostic
- Trial name
- 5 (NCT02438761)
- Testing
- PF-05212384
- Where
- 5 sites in France
- Volunteers
- 10 people
- Sponsor
- Institut Curie
Hormone Receptor Positive Breast Cancer
EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC)
This phase II, open-label, single-arm, study investigates the clinical benefit of everolimus combined with endocrine therapy (ET) in hormone receptor-positive (HR+), metastatic breast cancer (MBC) patients who progressed on prior…
- Trial name
- MBC (NCT07646171)
- Testing
- Everolimus (Afinitor) tablets with endocrine therapy, Blood draw for biomarker and genetic analysis
- Where
- Israel
- Volunteers
- 19 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Metastatic Breast Cancer
Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer
This is a phase II, exploratory, open-label, single arm study of BYL719 monotherapy, a selective phosphatidylinositol 3-kinase (PI3K) alpha inhibitor, in adult patients with advanced metastatic breast cancer progressing after…
- Trial name
- PIKNIC (NCT02506556)
- Testing
- BYl719
- Where
- Australia
- Volunteers
- 38 people
- Sponsor
- Peter MacCallum Cancer Centre, Australia
Pre-menopausal Breast Cancer, PI3K Pathway Inhibition
A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer
Based on the evidence acquired in the post-menopausal setting with everolimus and on pre-clinical evidences supporting the investigation of PI3K inhibitors, such as alpelisib and buparlisib, in combination with endocrine therapy…
- Trial name
- B-YOND (NCT02058381)
- Testing
- alpelisib (BYL719), buparlisib (BKM120)
- Where
- 15 sites in Hong Kong, South Korea and 2 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals