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
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.
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
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
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
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
Congenital Adrenal Hyperplasia, CAH - Congenital Adrenal Hyperplasia
Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia
This is a multicenter Phase 2, multiple dose, dose escalation study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SPR001 in adult patients with classic congenital adrenal hyperplasia (CAH).
- Trial name
- NCT03257462
- Testing
- SPR001
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Spruce Biosciences
Solid Tumor, Multiple Myeloma
Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)
This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly, every other week. or a every three week infusion.
- Trial name
- NCT00701103
- Testing
- Dalotuzumab
- Volunteers
- 80 people
- Sponsor
- Merck Sharp & Dohme LLC
Solid Tumors and Hematologic Malignancy
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment…
- Trial name
- NCT02431260
- Testing
- INCB054329 Monotherapy
- Where
- 12 sites in United States
- Volunteers
- 69 people
- Sponsor
- Incyte Corporation
Cirrhosis
A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg
OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy.
- Trial name
- NCT01048788
- Testing
- OPC-41061
- Where
- 6 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Parkinson's Disease (PD)
Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067
The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.
- Trial name
- NCT02071810
- Testing
- BIA 9-1067
- Where
- France
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Hepatitis B
A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years
This study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from…
- Trial name
- NCT05561673
- Testing
- GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system, GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline