Clinical trials: Dose-escalation
Neoplasms
Dose Finding Study of BI 836880 in Patients With Solid Tumors
This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously. The eligible patient population will be patients with advanced solid tumours.
- Trial name
- NCT02674152
- Testing
- BI 836880
- Where
- 3 sites in France, Germany
- Volunteers
- 29 people
- Sponsor
- Boehringer Ingelheim
Hantavirus Pulmonary Infection, Immunisation
Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device
This is a Phase 1, randomized, placebo controlled, double-blind, dose escalation trial of 48 males and non-pregnant females, 18-49 years old, inclusive, who are in good health and meet all eligibility criteria.
- Trial name
- NCT03682107
- Testing
- Andes virus DNA vaccine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gastrointestinal Neoplasms; Esophageal, Stomach, Pancreas, Colon Neoplasms; Malignant Tumors of Digestive Organ; Advanced Gastrointestinal Malignancies
A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
The purpose of this study is to evaluate the safety of TAK-164 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and schedule.
- Trial name
- NCT03449030
- Testing
- TAK-164, 89Zr-TAK-164
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Recurrent Glioblastoma, Recurrent Gliosarcoma
Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma
This is a phase 0/1 dose-escalation trial to determine the maximum tolerated dose of Mycophenolate Mofetil (MMF) when administered with radiation, in patients with glioblastoma or gliosarcoma.
- Conditions
- Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV, Newly Diagnosed Glioblastoma
- Trial name
- NCT04477200
- Testing
- Mycophenolate Mofetil, Radiation Therapy, Re-resection (as part of standard of care)
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of Michigan Rogel Cancer Center
Metastatic Breast Cancer
A Confirmation Study of Eribulin in Combination With Capecitabine
This is a Phase 1b/2, multi-center, open-label, dose escalation (in 2 different dosing schedules [1 and 2]) and dose-confirmation study of eribulin administered in combination with capecitabine.
- Trial name
- NCT01323530
- Testing
- Eribulin mesylate, Capecitabine
- Where
- 10 sites in Bulgaria, Russia and 1 more
- Volunteers
- 76 people
- Sponsor
- Eisai Limited
Dengue
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
- Trial name
- NCT00290147
- Testing
- D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Multiple Myeloma
Dasatinib in Combination With Revlimid (and Dexamethasone)
The purpose of this study was to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and a low dose dexamethasone for the treatment of relapsed or refractory multiple myeloma.
- Trial name
- NCT00560391
- Testing
- Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg, Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg, Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 35 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
- Trial name
- NCT01559090
- Testing
- MEDI-546
- Where
- 6 sites in Japan
- Volunteers
- 17 people
- Sponsor
- AstraZeneca
Facial isSCC
Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Adults With Facial isSCC
Open label, dose escalation to evaluate safety.
- Trial name
- isSCC (NCT05421013)
- Testing
- STP705
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Sirnaomics
Atopic Dermatitis
A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study of Bermekimab (MABp1) in patients with atopic dermatitis.
- Trial name
- NCT03496974
- Testing
- Bermekimab Monoclonal Antibody 200 mg, Bermekimab Monoclonal Antibody 400 mg
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Janssen Research & Development, LLC
VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and…
- Trial name
- TEXT-TKR (NCT03251482)
- Testing
- JNJ-64179375 0.3 mg/kg, JNJ-64179375 0.6 mg/kg, JNJ-64179375 1.2 mg/kg
- Where
- 103 sites in United States, Argentina and 14 more
- Volunteers
- 308 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study of LY2541546 in Healthy Postmenopausal Women
The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.
- Trial name
- NCT01742078
- Testing
- LY2541546 - IV, LY2541546 - SC
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Amyloidosis
A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis
This study evaluates the safety and efficacy of carfilzomib used in combination with thalidomide and dexamethasone in patients with relapsed AL amyloidosis.
- Trial name
- CATALYST (NCT02545907)
- Testing
- Carfilzomib, Thalidomide, Dexamethasone
- Where
- 14 sites in United Kingdom
- Volunteers
- 10 people
- Sponsor
- University College, London
Spinal Muscular Atrophy Type II, Spinal Muscular Atrophy Type III
Clinical Trial of Sodium Phenylbutyrate in Children With Spinal Muscular Atrophy Types II or III
The purpose of this study is to identify the maximum tolerated dosage of sodium phenylbutyrate in children with spinal muscular atrophy types II or III; and to determine if the drug has an effect on SMN mRNA and protein levels.
- Trial name
- NPTUNE01 (NCT00439569)
- Testing
- sodium phenylbutyrate
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Westat
Solid Tumors
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or…
- Trial name
- NCT02598960
- Testing
- BMS-986156, Nivolumab
- Where
- 27 sites in United States, Australia and 8 more
- Volunteers
- 295 people
- Sponsor
- Bristol-Myers Squibb
Cytomegalovirus Infection
Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients
This was a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study of brincidofovir (BCV) administered orally once or twice weekly for up to 11 weeks.
- Trial name
- NCT00942305
- Testing
- Brincidofovir
- Where
- 26 sites in United States
- Volunteers
- 239 people
- Sponsor
- Jazz Pharmaceuticals
Malignant Solid Tumor
ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan
Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect…
- Trial name
- NCT00836888
- Testing
- ONO-4538
- Where
- Japan
- Volunteers
- 17 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infection
A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine
This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.
- Trial name
- NCT01764256
- Testing
- P2-VP8 subunit rotavirus vaccine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- PATH
Dumping Syndrome
Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome
multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome
- Trial name
- NCT01637272
- Testing
- SOM230
- Where
- 17 sites in United States, Belgium and 3 more
- Volunteers
- 43 people
- Sponsor
- Novartis Pharmaceuticals
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