PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02303392: Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma
Official title: A Dose Escalation Study of Selinexor (KPT-330), a Selective Inhibitor of Nuclear Export, and Ibrutinib, a Bruton's Tyrosine Kinase Inhibitor, in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma
Conditions: Prolymphocytic Leukemia
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Summary: This phase I trial studies the side effects and best dose of selinexor when given together with ibrutinib in treating patients with chronic lymphocytic leukemia or aggressive non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as selinexor, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving selinexor together with ibrutinib may be a better treatment for chronic lymphocytic leukemia or aggressive non-Hodgkin lymphoma.
Interventions:
description: Given PO
name: Selinexor
other_name: CRM1 Nuclear Export Inhibitor KPT-330
KPT-330
SINE KPT-330
Selective Inhibitor of Nuclear Export KPT-330
type: Drug
description: Given PO
name: Ibrutinib
other_name: BTK Inhibitor PCI-32765
CRA-032765
Imbruvica
PCI-32765
type: Drug
description: Correlative studies
name: Pharmacological Study
other_name: pharmacological studies
type: Other
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
Study arms:
design_group_description: Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (selinexor, ibrutinib)
design_group_type: Experimental
Sponsor: Ohio State University Comprehensive Cancer Center
Collaborators: Karyopharm Therapeutics, Inc.
Drug name mappings:
name: 伊布替尼
lang: CN
name: Ibrutinib
lang: EN
name: イブルチニブ
lang: JP
name: 塞利尼索
lang: CN
name: Selinexor
lang: EN
Clinical trial NCT04819438: Riluzole Orodispersible Film Replicate Bioavailability
Official title: Comparative Bioavailability Study of a New Riluzole Orodispersible Film vs. a Marketed Oral Reference (Rilutek® Tablets) in Healthy Male and Female Volunteers
Conditions: Healthy Participants
Summary: The objective of the study is to compare the pharmacokinetic profile of riluzole after replicate single dose of the novel orodispersible film test formulation and of the marketed reference Rilutek® tablets and to evaluate their bioequivalence.
Interventions:
description: Before each administration, the subjects will drink 20 mL of still mineral water in order to wet their mouth. Afterwards, using gloves, the investigator or deputy will take the orodispersible film (32.0x22.0 mm) out of the provided pouch and place the product directly on the top surface (dorsal aspect) of the subjects' tongue.
name: Riluzole 50 mg orodispersible film
other_name: Test product (T)
type: Drug
description: One film-coated tablet will be swallowed (without chewing) with 150 mL of still mineral water.
name: Rilutek® 50 mg riluzole tablets
other_name: Reference product (R)
type: Drug
Study arms:
design_group_description: Riluzole orodispersible film (test): The subjects will be treated with one orodispersible film containing 50 mg of riluzole in two out of the four study periods according to the randomisation sequence Rilutek® (reference): The subjects will be treated with one film-coated tablet containing 50 mg of riluzole in two out of the four study periods according to the randomisation sequence.
design_group_title: Reference/Test/Reference/Test
design_group_type: Experimental
design_group_description: Riluzole orodispersible film (test): The subjects will be treated with one orodispersible film containing 50 mg of riluzole in two out of the four study periods according to the randomisation sequence Rilutek® (reference): The subjects will be treated with one film-coated tablet containing 50 mg of riluzole in two out of the four study periods according to the randomisation sequence.
design_group_title: Test/Reference/Test/Reference
design_group_type: Experimental
Sponsor: Cross Research LLC
Collaborators: Zambon SpA
Drug name mappings:
name: 利鲁唑
lang: CN
name: Riluzole
lang: EN
name: リルゾール
lang: JP
Clinical trial NCT04898907: Study Developed to Evaluate the Effect of ANG-3777 on QT/QTc Interval
Official title: A Single Part, Four-Way Crossover, Randomized, Partially-Blinded Study to Evaluate the Effect of Intravenous ANG-3777 on Baseline-Adjusted QT/QTc Interval in the Fasted State in Healthy Male and Female Subjects
Conditions: Healthy Volunteer
Summary: The purpose of this study is to evaluate the effect of ANG-3777 on placebo-corrected change from baseline, QT/corrected QT (QTc) interval, following single intravenous (IV) doses in healthy volunteer adults.
Interventions:
description: Arms assigned to this intervention will receive 2 mg/kg, IV, Fasted
name: ANG-3777 (Therapeutic Dose)
other_name: Hepatocyte growth factor mimetic
type: Drug
description: Arms assigned to this intervention will receive 6 mg/kg, IV, Fasted
name: ANG-3777 (Supra-therapeutic Dose)
other_name: Hepatocyte growth factor mimetic
type: Drug
description: Arms assigned to this intervention will receive normal saline, IV, Fasted
name: Placebo
other_name: Normal Saline
type: Drug
description: Arms assigned to this intervention will receive 400 mg, Oral, Fasted
name: Moxifloxacin Hydrochloride
type: Drug
Study arms:
design_group_description: Administered IV as a single dose on two occasions for 30 minutes on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration.
design_group_title: ANG-3777 (Therapeutic Dose)
design_group_type: Experimental
design_group_description: The placebo will be administered as a single dose on separate occasions intravenously as 30-minute infusions on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration.
design_group_title: Normal Saline
design_group_type: Placebo Comparator
design_group_description: The comparator will be administered as a single dose oral Moxifloxacin Hydrochloride tablet (open-label), with a total of 240 mL of water. There will be a minimum washout of 3 days between each study drug administration.
design_group_title: Moxifloxacin Hydrochloride
design_group_type: Active Comparator
design_group_description: Administered IV as a single dose on two occasions for 30 minutes on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration.
design_group_title: ANG-3777 (Supra-therapeutic Dose)
design_group_type: Experimental
Sponsor: Angion Biomedica Corp.
Collaborators: Quotient Sciences Ltd.
Drug name mappings:
name: Refanalin
lang: EN
Clinical trial NCT05828212: Evaluate the Safety and Efficacy of CAR-T Cells in the Treatment of R/R Neuromyelitis Optica
Official title: A Study on the Safety and Efficacy of Chimeric Antigen Receptor T Cells in the Treatment of Recurrent/Refractory Neuromyelitis Optica
Conditions: Neuromyelitis Optica
Summary: This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD19 CAR-T therapy for patients with relapsed or refractory Neuromyelitis Optica, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.
Interventions:
description: CAR-T cells in the treatment of R/R neuromyelitis optica
name: CAR-T cells injection
type: Drug
Study arms:
design_group_description: Recurrent/Refractory Neuromyelitis Optica
design_group_title: Treatment Group
design_group_type: Experimental
Sponsor: Zhejiang University
Collaborators: Shanghai Yake Biotechnology Co., Ltd
Drug name mappings:
name: Anti-CD19 CART cell therapy (YaKe Biotechnology)
lang: EN
Clinical trial NCT01785329: Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects
Official title: A Randomized Study of the Relative Bioavailability, Pharmacodynamics, Safety of SAR236553 (REGN727) After Single Subcutaneous Administration at 3 Different Injection Sites in Healthy Subjects
Conditions: Hypercholesterolemia
Summary: Primary Objective:
To assess the relative bioavailability of a single subcutaneous dose of alirocumab SAR236553 (REGN727) administered at 3 different injection sites in healthy subjects.
Secondary Objectives:
* To assess the pharmacodynamic effect of a single subcutaneous dose of alirocumab SAR236553 (REGN727) on serum low-density lipoprotein cholesterol and other lipids and apolipoproteins.
* To assess the safety of a single subcutaneous dose of alirocumab SAR236553 (REGN727).
* To assess the immunogenicity of a single subcutaneous dose of alirocumab SAR236553 (REGN727).
Interventions:
description: Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
name: alirocumab SAR236553 (REGN727)
type: Drug
Study arms:
design_group_description: alirocumab SAR236553 (REGN727) - Dose A - Injection in healthy subjects through subcutaneous administration in the abdomen.<br/>alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)
design_group_title: alirocumab SAR236553 (REGN727) - Dose A
design_group_type: Experimental
design_group_description: alirocumab SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm.
design_group_title: alirocumab SAR236553 (REGN727) - Dose B
design_group_type: Experimental
design_group_description: alirocumab SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh.
design_group_title: alirocumab SAR236553 (REGN727) - Dose C
design_group_type: Experimental
Sponsor: Sanofi
Collaborators: Regeneron Pharmaceuticals, Inc.
Drug name mappings:
name: 阿利西尤单抗
lang: CN
name: Alirocumab
lang: EN
Clinical trial NCT01638325: A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants
Official title: A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Single Subcutaneous Injections of Insulin Lispro With BioChaperone Excipient in Healthy Volunteers
Conditions: Healthy Participants
Summary: BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.
Interventions:
description: Administered SC
name: Insulin Lispro
other_name: Humalog
LY275585
type: Drug
description: Administered SC
name: BC106 insulin lispro
other_name: BioChaperone insulin lispro
type: Drug
Study arms:
design_group_description: 15 international units (IU) insulin lispro administered once subcutaneously (SC) during 1 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.
design_group_title: Insulin Lispro
design_group_type: Active Comparator
design_group_description: 15 up to 30 IU BC106 insulin lispro administered once SC during 2 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.
design_group_title: BC106 Insulin Lispro
design_group_type: Experimental
Sponsor: Adocia SA
Collaborators: Eli Lilly & Co.
Drug name mappings:
name: 超速效赖脯胰岛素(Adocia SA)
lang: CN
name: Ultra fast-acting insulin lispro (Adocia SA)
lang: EN
Clinical trial NCT04201145: Pembrolizumab + Defactinib In Pleural Mesothelioma
Official title: Phase IA-IB Open-label, Non-randomized, Neoadjuvant Treatment With Combination Pembrolizumab and Defactinib for Patients With Surgically Resectable Malignant Pleural Mesothelioma
Conditions: Malignant Pleural Mesothelioma
Summary: This research study is studying a new drug combination of Pembrolizumab and Defactinib followed by surgical resection possible treatment for resectable Malignant Pleural Mesothelioma (MPM).
The names of the study drugs involved in this study are:
* Pembrolizumab
* Defactinib
Interventions:
description: IV, predetermined dosage, twice per cycle
name: Pembrolizumab
other_name: Keytruda®
type: Drug
description: Defactinib oral, twice daily, per predetermined dose and predetermined duration as defined by cohort
name: Defactinib
other_name: PF-04554878
type: Drug
Study arms:
design_group_description: Treatment with pembrolizumab as a single agent for 56 days<br/>- 2 doses during treatment cycle, intravenous, at predetermined protocol dose
design_group_title: Run in cohort: pembrolizumab only
design_group_type: Experimental
design_group_description: Treatment with Defactinib in combination with Pembrolizumab for 12 days<br/>* Defactinib oral, twice daily, per predetermined dose for 12 days of treatment in combination<br/>* Pembrolizumab via infusion, twice per cycle, per predetermined dose
design_group_title: Cohort 1: pembrolizumab + defactinib 12 days
design_group_type: Experimental
design_group_description: Treatment with defactinib in combination with pembrolizumab to 35 days<br/>* Defactinib oral, twice daily, per predetermined dose for 35 days of treatment in combination<br/>* Pembrolizumab via infusion, twice per cycle, per predetermined dose
design_group_title: Cohort 2: pembrolizumab + defactinib 35 days
design_group_type: Experimental
design_group_description: Tolerated phase IA regimen will be administered in a phase IB expansion cohort
design_group_title: Expansion cohort
design_group_type: Experimental
Sponsor: Dana-Farber Cancer Institute, Inc.
Collaborators: Merck Sharp & Dohme Corp.
Drug name mappings:
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
name: 地法替尼
lang: CN
name: Defactinib
lang: EN
Clinical trial NCT05767060: BAT7104 Injection in Patients With Advanced Malignant Tumors.
Official title: A Multi-center, Open Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Clinical Efficacy of BAT7104 Injection in Patients With Advanced Malignant Tumors.
Conditions: Advanced Malignant Tumor
Summary: A multi-center, open phase Ia/Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors.
Interventions:
description: According to the protocol, each dose group is given intravenous infusion at the rate of mg/kg, and the recommended infusion time is ≥ 60 minutes. Once every two weeks (Q2W), on the first day of each cycle.
name: BAT7104 injection
other_name: Recombinant anti-PD-L1/CD47 bispecific antibody injection
type: Drug
Study arms:
design_group_description: frequency: Q2W
design_group_title: BAT7104 Injection 0.1 mg/kg
design_group_type: Experimental
design_group_description: frequency: Q2W
design_group_title: BAT7104 Injection 0.3 mg/kg
design_group_type: Experimental
design_group_description: frequency: Q2W
design_group_title: BAT7104 Injection 1 mg/kg
design_group_type: Experimental
design_group_description: frequency: Q2W
design_group_title: BAT7104 Injection 3 mg/kg
design_group_type: Experimental
design_group_description: frequency: Q2W
design_group_title: BAT7104 Injection 10 mg/kg
design_group_type: Experimental
design_group_description: frequency: Q2W
design_group_title: BAT7104 Injection 20 mg/kg
design_group_type: Experimental
design_group_description: frequency: Q2W
design_group_title: BAT7104 Injection 40 mg/kg
design_group_type: Experimental
Sponsor: Bio-Thera Solutions, Ltd.
Collaborators: Sun Yat-Sen University
Drug name mappings:
name: BAT-7104
lang: EN
Clinical trial NCT01676792: SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
Official title: A Pilot Study to Assess the Efficacy & Safety of Topical SR-T100 Gel in the Treatment of Human Vulva Pre-cancerous Lesions (Vulvar Intraepithelial Neoplasia; VIN) & Cutaneous Condyloma(External Genital Warts; EGWs)
Conditions: Vulvar Intraepithelial Neoplasia
Genital Warts
Summary: This pilot clinical study is to evaluate the efficacy & safety of SR-T100 gel (2.3% of SM in Solanum undatum plant extract) in patients with VIN(s) or EGW(s).
Interventions:
description: Self administered topical SR-T100 gel on lesion(s) including its peripheral normal skin approximately 1cm around the lesion with the amount of 0.02 g/cm squared with occlusive dressing once daily. Patients who is unable to tolerate with occlusive dressing is instructed 3 times daily in the morning, afternoon & before bed time. Medication should be reapply after bathing or cleaning.
name: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
other_name: SR-T100 gel
type: Drug
Study arms:
design_group_title: Lesion reduction
design_group_type: Experimental
Sponsor: National Cheng Kung University Hospital
Collaborators: G&E Herbal Biotechnology Co., Ltd.
Drug name mappings:
name: Solamargine
lang: EN
Clinical trial NCT02259686: Cardiovascular Effects of Apelin In Healthy Volunteers
Official title: Cardiovascular Effects of Apelin In Healthy Volunteers
Conditions: Healthy
Summary: Apelin is an endogenous peptide with physiological actions in the cardiovascular system. Apelin can modulate vasomotor tone and is a potent endogenous inotrope. In a series of clinical studies, we have shown that apelin causes peripheral and coronary vasodilatation and increased cardiac contractility. We wish to study and compare the cardiovascular effects of subcutaneous versus intravenous apelin. We specifically wish to determine how different methods of apelin administration affect cardiac output and peripheral vascular resistance in healthy volunteers
Interventions:
description: single subcutaneous injection of Apelin 1mg subcutaneous
name: Apelin 1mg subcutaneous
other_name: 1mg Sc
type: Drug
description: 15 minute intravenous bolus of Apelin 1mg intravenous
name: Apelin 1mg intravenous
other_name: 1mg iv
type: Drug
description: single subcutaneous injection of Apelin 5mg subcutaneous
name: Apelin 5mg subcutaneous
other_name: 5mg Sc
type: Drug
description: 15 minute intravenous infusion of Apelin 5mg intravenous
name: Apelin 5mg intravenous
other_name: 5mg iv
type: Drug
description: 24 hour continuous subcutaneous infusion of Apelin 10 mg subcutaneous
name: Apelin 10 mg subcutaneous
other_name: 10mg sc
type: Drug
Study arms:
design_group_description: 5 Healthy volunteers
design_group_title: Protocol 1. Apelin 1mg doses
design_group_type: Experimental
design_group_description: 5 Healthy volunteers
design_group_title: Protocol 2. Apelin 5mg doses
design_group_type: Experimental
design_group_description: 5 Healthy volunteers
design_group_title: Protocol 3. Apelin 10mg single dose
design_group_type: Experimental
Sponsor: The University of Edinburgh
Collaborators: NHS Lothian
Drug name mappings:
name: 爱帕琳肽
lang: CN
name: Apelin
lang: EN
Clinical trial NCT05468307: A Study of GC203 TIL in Advanced Gynecologic Tumors (10hospital)
Official title: A Clinical Study of Engineered Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Advanced Gynecologic Tumors
Conditions: Advanced Gynecologic Tumors
TIL Engineered With Membrane-Binding Cytokine
Treatment Side Effects
Effects of Immunotherapy
Summary: This study is to investigate the safety and efficacy on TIL engineered with membrane-binding cytokine (GC203 TIL) for the treatment of patients with advanced gynecologic tumors. Autologous TILs from tumor resections or biopsies are first gene modified (engineered with membrane-binding cytokine) and than expanded before i.v. infusion into the patient after NMA lymphodepletion treatment with cyclophosphamide.
Interventions:
description: Adoptive transfer of 2x10^8-1x10^10 autologous TIL engineered with membrane-binding cytokine to patients i.v. in 30-120 minutes.
name: Membrane Bound Cytokine Modified TIL
type: Biological
Study arms:
design_group_description: 2x10^8-1x10^10 in vitro expanded autologous TIL engineered with membrane-binding cytokine (GC203 TIL) will be infused i.v. to patients with advanced gynecologic tumors after NMA lymphodepletion treatment with cyclophosphamide.
design_group_title: Membrane Bound Cytokine Modified TIL
design_group_type: Experimental
Sponsor: Shanghai Gencells Therapeutics Co., Ltd.
Collaborators: Shanghai No. 10 People's Hospital
Drug name mappings:
name: GC203 TIL(Shanghai Juncell Therapeutics)
lang: EN
Clinical trial NCT05085418: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Immune Nephritis
Official title: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Immune Nephritis
Conditions: Immune Nephritis
Autoimmune Diseases
Lupus Nephritis
Summary: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Immune Nephritis
Interventions:
description: Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection
name: Assigned Interventions CD19/BCMA CAR T-cells
type: Biological
Study arms:
design_group_description: Administration of CD19/BCMA CAR T-cells A dose levels of 1-4*10E6/kg are administrated for each subject.
design_group_title: Treatment of Immune Nephritis
design_group_type: Experimental
Sponsor: Zhejiang University
Collaborators: Shanghai Yake Biotechnology Co., Ltd
Drug name mappings:
name: CD19/BCMA CAR Tcells therapy  (Yake Biotechnology)
lang: EN
Clinical trial NCT02372318: Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity
Official title: Nalmefene Challenge to Modulate Neural Reactivity to Alcohol-related and Emotional Cues in Non-treatment Seeking Alcohol Dependent Participants
Conditions: Alcoholism
Summary: The aim of this study is to use functional Magnetic Resonance Imaging (fMRI) to measure neural reactivity to alcohol-related and emotional cues in alcohol dependent subjects following a single dose of the opioid receptor modulator nalmefene. The study will be done in a cross over design with nalmefene versus placebo.
Interventions:
description: 18mg of Nalmefen will be administered orally
name: Nalmefene
other_name: Selincro
type: Drug
description: Placebo tablet
name: Placebo
type: Drug
Study arms:
design_group_description: Participants will receive 18mg Nalmefene two hours prior to fMRI measurement. During fMRI scanning alcohol cues will be presented.
design_group_title: Nalmefene Challenge
design_group_type: Experimental
design_group_description: Participants will receive Placebo two hours prior to fMRI measurement. During fMRI scanning alcohol cues will be presented.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Zentralinstitut für Seelische Gesundheit
Collaborators: Lundbeck GmbH
Drug name mappings:
name: 盐酸纳美芬
lang: CN
name: Nalmefene Hydrochloride
lang: EN
name: ナルメフェン塩酸塩水和物
lang: JP