Clinical trials: Phase 2
Biliary Tract Cancer (BTC)
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
- Trial name
- TELE-ABC (NCT03790111)
- Testing
- telotristat ethyl
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- TerSera Therapeutics LLC
Influenza
Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers
The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune…
- Trial name
- NCT01229371
- Testing
- Inflexal V influenza vaccine (CSL HA Antigen) 2010, Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011
- Where
- 2 sites in Switzerland
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Pulmonary Tuberculosis
Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis
The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg, 200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days, in patients with uncomplicated…
- Trial name
- NCT00401271
- Testing
- OPC-67683, Rifafour e-275
- Where
- 3 sites in South Africa
- Volunteers
- 54 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
Bipolar Depression
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD).
- Trial name
- NCT03965871
- Testing
- Esketamine DPI - low dose, Esketamine DPI - medium dose, Esketamine DPI - high dose
- Where
- 12 sites in Poland
- Volunteers
- 88 people
- Sponsor
- Celon Pharma SA
Healthy
A Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Participants
The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328.
- Trial name
- NCT02074800
- Testing
- CNTO 328 (Sp2/0-derived), CNTO 328 (CHO-derived)
- Where
- 2 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Centocor, Inc.
Meningococcal Disease
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously…
- Trial name
- NCT01992536
- Testing
- MenABCWY+OMV, MenABCWY+¼OMV
- Where
- 13 sites in United States, Poland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Neoplasms
A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan
N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin.
- Trial name
- NCT00421811
- Testing
- ADH-1, melphalan
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Adherex Technologies, Inc.
Polycythemia Vera (PV)
Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply
This is a Phase 2 single arm study to investigate efficacy and safety of P1101 for adult Japanese patients with PV.
- Trial name
- NCT04182100
- Testing
- P1101, Low-dose aspirin, Phlebotomy
- Where
- 8 sites in Japan
- Volunteers
- 29 people
- Sponsor
- PharmaEssentia Japan K.K.
Locally Advanced Breast Cancer, Metastatic Breast Cancer
Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer
Phase II, randomized, open-label study, designed to evaluate the preliminary efficacy and safety of tenalisib at two dose levels in 40 patients with locally advanced or metastatic breast cancer.
- Trial name
- NCT05021900
- Testing
- Tenalisib 800mg, Tenalisib 1200mg
- Where
- 3 sites in Georgia
- Volunteers
- 40 people
- Sponsor
- Rhizen Pharmaceuticals SA
Osteoarthritis of the Knee
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects…
- Trial name
- NCT02067611
- Testing
- X0002
- Where
- 20 sites in United States
- Volunteers
- 216 people
- Sponsor
- Lina Xu
Schizophrenia
Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia
This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia
- Trial name
- NCT03150771
- Testing
- Aripiprazole
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Solid Tumors
Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors
What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be…
- Trial name
- NCT01190644
- Testing
- Sotatercept
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers, Pharmacokinetics of Mirabegron
A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously
This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.
- Trial name
- NCT01297192
- Testing
- solifenacin succinate, mirabegron
- Where
- France
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Head and Neck Squamous Cell Carcinoma
FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma
The goal of this FID-007 Clinical Trial is to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
- Trial name
- HNSCC (NCT06332092)
- Testing
- FID007
- Where
- 6 sites in United States
- Volunteers
- 46 people
- Sponsor
- Fulgent Pharma LLC.
Chronic Obstructive Pulmonary Disease
A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
This is a phase II clinical trial to evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT05987371
- Testing
- TQC3721 suspension for inhalation, Salbutamol sulfate inhalation aerosol
- Where
- 11 sites in China
- Volunteers
- 75 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Carcinoma, Non Small Cell Lung
Gemcitabine/Platinum Containing Regimens as Preoperative Chemotherapy for Patients With Non Small Cell Lung Cancer
To study the efficacy and tolerability of gemcitabine/platinum chemotherapy in non small cell lung cancer
- Trial name
- NCT00191230
- Testing
- gemcitabine, carboplatin, cisplatin
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Eli Lilly and Company
Hypertension, Diabetes
Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes
The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus…
- Trial name
- NCT01496430
- Testing
- Azilsartan medoxomil
- Where
- 68 sites in United States
- Volunteers
- 105 people
- Sponsor
- Takeda
Relapsed or Refractory Peripheral T-Cell Lymphoma
Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy
Phase II study designed to investigate antitumor activity in terms of objective response rate (ORR) of tipifarnib subjects with advanced Peripheral T-Cell Lymphoma (PTCL).
- Trial name
- PTCL (NCT02464228)
- Testing
- Tipifarnib
- Where
- 13 sites in United States, South Korea and 1 more
- Volunteers
- 65 people
- Sponsor
- Kura Oncology, Inc.
Salivary Gland Neoplasms
A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
The purpose of the study is to evaluate the overall response rate (ORR) of apalutamide in combination with a gonadotropin-releasing hormone (GnRH) agonist in participants with androgen receptor (AR) expressing locally advanced or…
- Trial name
- YATAGARASU (NCT04325828)
- Testing
- Apalutamide, GnRH Agonist
- Where
- 7 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Janssen Pharmaceutical K.K.
Endometrial Cancer
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
- Trial name
- NCT06481592
- Testing
- Lifileucel
- Where
- 12 sites in United States
- Volunteers
- 60 people
- Sponsor
- Iovance Biotherapeutics, Inc.
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