Clinical trials: Dose-escalation
Ovarian Neoplasms, Peritoneal Neoplasms
BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer
This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced, platinum sensitive…
- Trial name
- NCT01314105
- Testing
- BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
- Where
- 3 sites in Spain
- Volunteers
- 19 people
- Sponsor
- Boehringer Ingelheim
Pancreatitis, Acute Necrotizing
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Investigation of GSK3335065 Intravenous (IV) Infusion in Healthy Adults
GSK3335065 is being developed as a treatment for acute pancreatitis with the intent of reducing 3-hydroxykynurenine (3HK) levels to the normal range (or lower) and maintaining them at this level throughout the treatment period.
- Trial name
- NCT03245619
- Testing
- GSK3335065
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pancreatic Cancer
Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer
This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches.
- Trial name
- NCT00593866
- Testing
- INTENSITY MODULATED RADIOTHERAPY, Gemcitabine
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Michigan Rogel Cancer Center
Breast Cancer
Single Dose Partial Breast Radiotherapy
This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique.
- Trial name
- RSU (NCT00944528)
- Testing
- Radiosurgery
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Duke University
Breast Cancer
A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer
This study is being done for the following reasons: The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of neratinib that can be given safely with T-DM1.
- Trial name
- NCT02236000
- Testing
- Neratinib, T-DM1
- Where
- 15 sites in United States
- Volunteers
- 49 people
- Sponsor
- NSABP Foundation Inc
Single Ventricle Heart Disease After Fontan Surgery
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular…
- Trial name
- NCT02201342
- Testing
- Udenafil
- Where
- 6 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Mezzion Pharma Co. Ltd
Breast Cancer
Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer
The purpose of this research study is to determine the safety of RAD001 and the highest dose of this drug that can be given to people with HER2-positive metastatic breast cancer safely in combination with trastuzumab.
- Trial name
- NCT00458237
- Testing
- Everolimus, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Beth Israel Deaconess Medical Center
Malignant Solid Tumor
Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy
The goal of this trial is to learn about the antibody GEN1055 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with…
- Trial name
- NCT06391775
- Testing
- GEN1055, Pembrolizumab, Standard Chemotherapy
- Where
- 4 sites in United States, Spain
- Volunteers
- 21 people
- Sponsor
- Genmab
Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Leflunomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
This phase I/II trial studies the side effects and best dose of leflunomide in treating patients with multiple myeloma that has come back (relapsed) or has not responded to previous treatment (refractory).
- Trial name
- NCT02509052
- Testing
- Laboratory Biomarker Analysis, Leflunomide, Pharmacological Study
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- City of Hope Medical Center
Advanced Solid Tumor, Lung Cancer
Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor
This Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics (PK) profile and preliminary efficacy of intratumoral injection of Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in patients with advanced…
- Conditions
- Advanced Solid Tumor, Lung Cancer, Pancreas Cancer, Breast Cancer
- Trial name
- CNSI-Fe(II) (NCT06048367)
- Testing
- CNSI-Fe(II) 30 mg, CNSI-Fe(II) 60 mg, CNSI-Fe(II) 90 mg
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Sichuan Enray Pharmaceutical Sciences Company
Melanoma
APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma
You are being asked to take part in this study because you have metastatic (cancer that has spread) melanoma. The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given…
- Trial name
- NCT02706353
- Testing
- APX005M, Pembrolizumab
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- M.D. Anderson Cancer Center
Thrombocytopenia, MDS
Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)
The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.
- Conditions
- Thrombocytopenia, MDS, Myelodysplastic Syndromes, Refractory Cytopenias
- Trial name
- NCT00303472
- Testing
- Romiplostim
- Volunteers
- 72 people
- Sponsor
- Amgen
Overactive Bladder (OAB), Pharmacokinetics of Mirabegron
A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
The purpose of this study was to evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB. This study will also evaluated the safety and tolerability of mirabegron in pediatric participants with OAB and…
- Trial name
- Dolphin (NCT04641975)
- Testing
- Mirabegron
- Where
- 15 sites in Belgium, France and 8 more
- Volunteers
- 26 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Myelomonocytic Leukemia
A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib
The purpose of this study is to find out if treating Chronic Myelomonocytic Leukemia (CMML) with a study drug [ruxolitinib] can improve outcomes of patients with CMML.
- Trial name
- NCT01776723
- Testing
- Ruxolitinib
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Hypertension
A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood…
- Trial name
- BP CRUSH (NCT00791258)
- Testing
- amlodipine and olmesartan medoxomil tablets, hydrochlorothiazide tablets
- Where
- 72 sites in United States
- Volunteers
- 999 people
- Sponsor
- Daiichi Sankyo
Pneumococcal Vaccines
Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.
- Trial name
- NCT01537185
- Testing
- SPWCV+Alum 100 mcg, SPWCV+Alum 600 mcg, SPWCV+Alum 300 mcg
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- PATH Vaccine Solutions
Non-Hodgkin Lymphoma, Burkitt's Lymphoma
Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL)
This study evaluates ADCT-402 in participants with Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL). Participants will participate in a dose escalation phase (Part 1) and dose expansion (Part 2).
- Conditions
- Non-Hodgkin Lymphoma, Burkitt's Lymphoma, Chronic Lymphocytic Leukemia, Lymphoma, Large B-Cell, Diffuse
- Trial name
- NCT02669017
- Testing
- ADCT-402
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 183 people
- Sponsor
- ADC Therapeutics S.A.
Steroid-refractory Diamond-Blackfan Anemia (DBA)
Study of the Selective GlyT1 Inhibitor Bitopertin for Steroid-Refractory Diamond-Blackfan Anemia
Background: Diamond-Blackfan anemia (DBA) is an inherited disease that affects the bone marrow. People with DBA have chronic anemia that can be severe. Many must have frequent transfusions of red blood cells.
- Trial name
- NCT05828108
- Testing
- Bitopertin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Diffuse Large B-cell Lymphoma, Follicular Lymphoma
First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
The drug that will be investigated in the study is an antibody, GEN3009. Since this is the first study of GEN3009 in humans, the main purpose is to evaluate safety.
- Conditions
- Diffuse Large B-cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma
- Trial name
- NCT04358458
- Testing
- GEN3009, Epcoritamab
- Where
- 17 sites in United States, Belgium and 3 more
- Volunteers
- 46 people
- Sponsor
- Genmab
Alzheimer's Disease
Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease
Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the maximum tolerated dose of TB006, and to assess the immunogenicity of TB006…
- Trial name
- NCT05074498
- Testing
- TB006
- Where
- 18 sites in United States
- Volunteers
- 154 people
- Sponsor
- TrueBinding, Inc.