Clinical trials: Resistance, Disease
Solid Tumors, Advanced Triple Negative Breast Cancer
A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors
This is a Phase 1b/2a dose escalation and expansion, multi-center study to be conducted in 2 phases: Phase 1b Dose Escalation Part 1 (Doublet Therapy) Dose Escalation Part 2 (Triplet Therapy) Phase 2a Dose Expansion (Triplet…
- Conditions
- Solid Tumors, Advanced Triple Negative Breast Cancer, Advanced Hormone Receptor Positive/Endocrine Refractory Breast Cancer, Advanced Metastatic Castration-Resistant Prostate Cancer
- Trial name
- NCT03861403
- Testing
- TRX518, Cyclophosphamide, Avelumab
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Leap Therapeutics, Inc.
Ovarian Cancer
NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018)
The primary objective of this extension protocol is to evaluate the early safety of a new schedule of NGR-hTNF given weekly, instead of every 3 or 4 weeks, in a cohort of 12 patients randomized to the experimental arm A, as…
- Trial name
- NCT03804866
- Testing
- NGR-hTNF, Pegylated liposomal doxorubicin, Doxorubicin
- Where
- 4 sites in Italy
- Volunteers
- 14 people
- Sponsor
- AGC Biologics S.p.A.
Infantile Spasms (IS)
A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)
The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms
- Trial name
- NCT02829827
- Testing
- Radiprodil
- Where
- France
- Volunteers
- 3 people
- Sponsor
- UCB Biopharma S.P.R.L.
Critical Illness, Hyperglycemia
Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia
The aim of the study is to evaluate the beneficial effects of the administration of a complete diet rich in monounsaturated fatty acids (MUFA) and slow absorption carbohydrate in patients with stress hyperglycemia(T-Diet Plus…
- Conditions
- Critical Illness, Hyperglycemia, Dietary Modification, Metabolic Stress Hyperglycemia
- Trial name
- NCT01233726
- Testing
- T-Diet plus Diabet IR, ISOSOURCE PROTEIN FIBRE, GLUCERNA SELECT
- Where
- 2 sites in Spain
- Volunteers
- 159 people
- Sponsor
- Vegenat, S.A.
MRSA, Cystic Fibrosis
AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis
This is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis (CF).
- Trial name
- NCT03181932
- Testing
- Vancomycin inhalation powder
- Where
- 71 sites in United States, Canada
- Volunteers
- 188 people
- Sponsor
- Savara Inc.
Ovarian Cancer, High Grade Serous Adenocarcinoma of Ovary
ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer
This is a study to test the safety and efficacy with the combination of a next generation anti-CTLA-4 antibody, ONC-392, and anti-PD-1 antibody, pembrolizumab, in platinum resistant ovarian cancer patients.
- Conditions
- Ovarian Cancer, High Grade Serous Adenocarcinoma of Ovary, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Trial name
- PRESERVE-004 (NCT05446298)
- Testing
- ONC-392, Pembrolizumab
- Where
- 21 sites in United States
- Volunteers
- 58 people
- Sponsor
- OncoC4, Inc.
Bacteremia Caused by Gram-Negative Bacteria, Bacterial Pneumonia
A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection
This is a retrospective, observational, post-marketing study to evaluate the clinical response, microbiological response, mortality, and safety of intravenous polymyxin B and colistin methanesulfonate in patients with…
- Trial name
- NCT06966284
- Where
- Taiwan
- Volunteers
- 480 people
- Sponsor
- TTY Biopharm
Prostatic Neoplasms
Second Primary Cancers in Patients With Castration Resistant Prostate Cancer
This study aims at estimating the incidence of second primary malignancies as well as the overall survival among metastasized prostate cancer (mPC) and metastasized castrate-resistant prostate cancer (mCRPC) patients not treated…
- Trial name
- BOCARP (NCT02702908)
- Where
- Germany
- Volunteers
- 6,442 people
- Sponsor
- Bayer
Ovarian Cancer, Fallopian Tube Cancer
A Study of Chemotherapy Treatment for Patients With Ovarian Cancer
The primary objective is to determine whether LY573636-sodium (hereafter referred to as LY573636) is effective in treating platinum-resistant ovarian cancer.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- NCT00428610
- Testing
- LY573636-sodium
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 103 people
- Sponsor
- Eli Lilly and Company
Critical Illness
Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients.
- Trial name
- Aldea_02 (NCT00882427)
- Testing
- enhanced model predictive control algorithm (eMPC)
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- B. Braun Melsungen AG
Prostate Cancer, Castration-resistant Prostate Cancer
A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-resistant Prostate Cancer and Men With Metastatic Prostate Cancer
The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and…
- Conditions
- Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Prostate Cancer
- Trial name
- ASPIRE-PCa (NCT02066961)
- Where
- 93 sites in Algeria, Argentina and 25 more
- Volunteers
- 1,533 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metabolic Syndrome X
ROMEO (Rosuvastatin in Metabolic syndrOme)
The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome.
- Trial name
- NCT00395486
- Testing
- Rosuvastatin, Atorvastatin
- Where
- 3 sites in South Korea
- Volunteers
- 258 people
- Sponsor
- AstraZeneca
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Ovarian Cancer
A Phase 1b Study of Sevacizumab in Combination With Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with Chemotherapy in…
- Trial name
- NCT03763123
- Testing
- Sevacizumab, Paclitaxel, Topotecan
- Where
- 6 sites in China
- Volunteers
- 48 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
PTSD, Alzheimer Disease
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)
The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are: What is the safety of single ascending doses of the…
- Conditions
- PTSD, Alzheimer Disease, Brain Diseases, Neuro-Degenerative Disease
- Trial name
- NCT05921929
- Testing
- Fluoroethylnormemantine (FENM)
- Where
- Belgium
- Volunteers
- healthy volunteers welcome
- Sponsor
- ReST Therapeutics
Diabetes Mellitus
PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males
Primary objective: To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan \& Lee Insulin Lispro Injection with both EU - approved Humalog® and US - licensed Humalog® (Reference Products) in healthy male…
- Trial name
- NCT04235439
- Testing
- Gan & Lee Insulin Lispro Injection
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Gan and Lee Pharmaceuticals, USA
Aneurysmal Subarachnoid Hemorrhage
Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy
The purpose of this study is to determine the efficacy and safety of a diabetes-specific tube feed in comparison to an isocaloric, isonitrogenous standard enteral formula in critically ill patients receiving insulin treatment for…
- Trial name
- NCT02503527
- Testing
- Diben 1.5 kcal HP, Fresubin HP Energy Fibre (1.5 kcal)
- Where
- Austria
- Volunteers
- 28 people
- Sponsor
- Fresenius Kabi
Carcinoma, Ovarian Cancer
A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer
This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.
- Conditions
- Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms
- Trial name
- NCT01016054
- Testing
- AGS-8M4, Pegylated liposomal doxorubicin (PLD), gemcitabine
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Astellas Pharma Inc
Drug-resistant Epilepsy, Focal-Onset Seizures
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset…
- Trial name
- ARISE (NCT03373383)
- Testing
- Padsevonil
- Where
- 148 sites in United States, Australia and 17 more
- Volunteers
- 411 people
- Sponsor
- UCB Biopharma S.P.R.L.
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer
The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC).
- Trial name
- NCT07493512
- Testing
- Xaluritamig
- Where
- 14 sites in United States, Australia
- Volunteers
- 40 people
- Sponsor
- Amgen