Clinical trials: MTOR
Tuberous Sclerosis Complex-associated Refractory Seizures
A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures.
- Trial name
- EXIST-3 (NCT01713946)
- Testing
- RAD001, Antiepileptic drug (1 to 3 only), open label RAD001 (only used for post-extension phase)
- Where
- 104 sites in United States, Argentina and 23 more
- Volunteers
- 366 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs.
- Trial name
- BELLE-3 (NCT01633060)
- Testing
- Fulvestrant, BKM120
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Malignancies, Hematologic Malignancies
Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies
This is a Phase I, open label, dose escalation study of oral administration of MLN0128 in combination with paclitaxel, with/without trastuzumab, in participants with advanced solid malignancies.
- Trial name
- NCT01351350
- Testing
- MLN0128, paclitaxel, trastuzumab
- Where
- 3 sites in United States
- Volunteers
- 68 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Tuberous Sclerosis Complex (TSC), Lymphangioleiomyomatosis (LAM)
Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.
- Trial name
- EXIST-2 (NCT00790400)
- Testing
- Everolimus (RAD001)
- Where
- 25 sites in United States, Canada and 9 more
- Volunteers
- 118 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Hypertension
Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension
mTOR activation has been shown to be relevant in the development and progression of pulmonary hypertension. Inhibition of mTOR has been shown to reverse or regress pulmonary hypertension in animal models.
- Trial name
- NCT02587325
- Testing
- nab-sirolimus
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Aadi Bioscience, Inc.
Pancreatic Neuroendocrine Tumors (pNET)
BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.
This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy.
- Trial name
- NCT01658436
- Testing
- BEZ235 (Stage 1)
- Where
- 17 sites in United States, Austria and 7 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Cancers
Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038)
To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for whom a clinical benefit has been established in a prior parent trial (MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and…
- Trial name
- NCT00836927
- Testing
- Ridaforolimus Tablet, Ridaforolimus Intravenous (IV) Infusion
- Volunteers
- 7 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Solid Malignancies
Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of AZD2014
The main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug.
- Trial name
- NCT01026402
- Testing
- AZD2014
- Where
- 2 sites in United Kingdom
- Volunteers
- 172 people
- Sponsor
- AstraZeneca
Renal Cell Carcinoma
A Trial of Everolimis in Patients With Advanced Renal Cell Carcinoma.
Renal cell carcinoma (RCC) accounts for more than 200,000 new cases of cancer and over 100,000 cancer deaths annually in the World (Ferlay, et al., 2004).
- Trial name
- NCT01206764
- Testing
- RAD001
- Where
- 22 sites in Algeria, Egypt and 8 more
- Volunteers
- 143 people
- Sponsor
- Novartis Pharmaceuticals
Renal Angiomyolipoma
Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.
The purpose of this study was to assess the safety and efficacy of everolimus (Afinitor®) in Chinese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC).
- Trial name
- NCT03525834
- Testing
- Everolimus
- Where
- 5 sites in China
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Renal Cell Carcinoma
Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma
This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.
- Trial name
- NCT01223027
- Testing
- Dovitinib, Sorafenib
- Where
- 199 sites in United States, Argentina and 25 more
- Volunteers
- 564 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Myeloma, Diffuse Large B-Cell Lymphoma
Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to…
- Conditions
- Multiple Myeloma, Diffuse Large B-Cell Lymphoma, Glioblastoma Multiforme, Hepatocellular Carcinoma
- Trial name
- NCT01177397
- Testing
- CC-223
- Where
- 16 sites in United States, France and 2 more
- Volunteers
- 226 people
- Sponsor
- Celgene
Prostate Cancer Metastatic
A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY3023414 in combination with enzalutamide in men with prostate cancer.
- Trial name
- NCT02407054
- Testing
- LY3023414, Enzalutamide
- Where
- 36 sites in United States
- Volunteers
- 142 people
- Sponsor
- Eli Lilly and Company
Endometrial Neoplasms
A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.
- Trial name
- NCT01420081
- Testing
- PF-05212384
- Where
- 51 sites in United States, Australia and 6 more
- Volunteers
- 67 people
- Sponsor
- Pfizer
Advanced Cancer
Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer
After the fourth protocol amendment two study arms are evaluated in this clinical protocol: PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and PF-05212384 plus irinotecan.
- Trial name
- NCT01347866
- Testing
- PF-05212384, PD-0325901, irinotecan
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 105 people
- Sponsor
- Pfizer
Tumor, Tumor, Solid
Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)
A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes
- Conditions
- Tumor, Tumor, Solid, Metastasis, Metastatic Cancer
- Trial name
- NCT05103358
- Testing
- nab-sirolimus
- Where
- 166 sites in United States, Puerto Rico and 1 more
- Volunteers
- 128 people
- Sponsor
- Aadi Bioscience, Inc.
Breast Cancer
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.
- Trial name
- BOLERO-1 (NCT00876395)
- Testing
- Everolimus, Trastuzumab, Paclitaxel
- Where
- 140 sites in United States, Argentina and 26 more
- Volunteers
- 719 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Nonhematologic Malignancies
A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies
The purpose of this study was to evaluate the safety and to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and dosing schedules of oral TAK-228+TAK-117.
- Trial name
- NCT01899053
- Testing
- TAK-228, TAK-117
- Where
- 5 sites in United States, Spain and 1 more
- Volunteers
- 101 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
This research trial is testing a combination of two experimental drugs, MSC1936369B (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian…
- Conditions
- Locally Advanced Solid Tumor, Metastatic Solid Tumor, Breast Cancer, Non Small Cell Lung Cancer
- Trial name
- NCT01390818
- Testing
- MSC1936369B (pimasertib), SAR245409 (PI3K and mTOR inhibitor)
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 146 people
- Sponsor
- EMD Serono
Cancer
A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients
A phase 1 dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of PF-04691502 in adult cancer patients with solid tumors.
- Trial name
- NCT00927823
- Testing
- PF-04691502
- Where
- 7 sites in United States
- Volunteers
- 37 people
- Sponsor
- Pfizer