PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02012296: Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer
Official title: A Phase I/II Trial of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Mifepristone for Patients With Metastatic Castration Resistant Prostate Cancer (CRPC)
Conditions: Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Summary: This partially randomized phase I/II trial studies the side effects and best dose of enzalutamide and mifepristone when given together and to see how well they work in treating patients with metastatic hormone resistant prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide and mifepristone, may lessen the amount of androgens made by the body. It is not yet known whether enzalutamide is more effective with or without mifepristone in treating patients with prostate cancer.
Interventions:
description: Given PO
name: enzalutamide
other_name: MDV3100
XTANDI
selective androgen receptor modulator MDV3100
type: Drug
description: Given PO
name: mifepristone
other_name: Mifegyne
Mifeprex
RU-38486
type: Drug
description: Correlative studies
name: laboratory biomarker analysis
type: Other
description: Correlative studies
name: pharmacological study
other_name: pharmacological studies
type: Other
Study arms:
design_group_description: Patients receive enzalutamide PO per standard of care.
design_group_title: Treatment (enzalutamide)
design_group_type: Active Comparator
design_group_description: Patients receive enzalutamide PO and mifepristone PO.
design_group_title: Treatment (enzalutamide, mifepristone)
design_group_type: Experimental
Sponsor: The University of Chicago
Collaborators: National Cancer Institute
Drug name mappings:
name: 恩扎卢胺
lang: CN
name: Enzalutamide
lang: EN
name: エンザルタミド
lang: JP
name: 米非司酮
lang: CN
name: Mifepristone
lang: EN
name: ミソプロストール
lang: JP
Clinical trial NCT03023423: A Study of Daratumumab in Combination With Atezolizumab Compared With Atezolizumab Alone in Participants With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer
Official title: A Phase 1b/2, Open-Label, Randomized Study of Daratumumab Administered in Combination With Atezolizumab Compared With Atezolizumab Alone in Subjects With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions: Carcinoma, Non-Small-Cell Lung
Summary: The purpose of the study is to compare the overall response rate (ORR) in non-small cell lung cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab versus atezolizumab alone.
Interventions:
description: Participants will receive atezolizumab 1200 mg intravenously.
name: Atezolizumab
type: Drug
description: Participants will receive daratumumab 16 mg/kg intravenously.
name: Daratumumab
other_name: JNJ-54767414
type: Drug
Study arms:
design_group_description: Participants in Treatment Arm A will receive Atezolizumab 1,200 milligram (mg) intravenously (IV) on Day 1 of every 21-day cycle. Participants with confirmed disease progression based on RECIST 1.1 may cross over to Arm B and receive daratumumab and atezolizumab, provided crossover eligibility criteria are met.
design_group_title: Treatment Arm A: Atezolizumab
design_group_type: Experimental
design_group_description: Participants will receive daratumumab 16 milligram per kilogram [mg/kg] (Safety Run-in and Treatment Arm B) Intravenously (IV) weekly for 3 cycles (Day 1, 8 and 15), and Day 1 of every 21-day cycle thereafter. Atezolizumab will be administered at 1200 mg IV on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
design_group_title: Treatment Arm B: Atezolizumab and Daratumumab
design_group_type: Experimental
Sponsor: Janssen Research & Development LLC
Collaborators: Genentech, Inc.
Drug name mappings:
name: 达雷妥尤单抗
lang: CN
name: Daratumumab
lang: EN
name: ダラツムマブ（遺伝子組換え）
lang: JP
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT03252756: Effects of Cannabidiol in Alcohol Use Disorder
Official title: Effects of Cannabidiol in Alcohol Use Disorder
Conditions: Alcohol Use Disorder
Summary: The goal of the proposed project is to begin rigorous study of the clinically relevant effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD to those of placebo in AUD patients. Participants with AUD will be randomized to receive either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and motoric function), and physiological and psychological domains relevant to AUD (including self-reported craving, depression, and anxiety, and responses to personalized scripts designed to elicit stress- and cue-induced craving and anxiety). Assessments will be conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs. placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.
Interventions:
description: Saline taken by mouth (PO)
name: Placebo
type: Other
description: CBD taken by mouth (PO)
name: Phytocannabinoid cannabidiol (CBD)
type: Drug
Study arms:
design_group_description: 600mg/day Saline taken by mouth (PO) for 4 weeks, immediately followed by 1200mg saline/ day (PO) for an additional 4 weeks (8 total weeks).
design_group_title: Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks
design_group_type: Experimental
design_group_description: 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks).
design_group_title: CBD for 8 weeks
design_group_type: Experimental
Sponsor: NYU Langone Health
Collaborators: Tilray Brands, Inc.
National Institutes of Health
Drug name mappings:
name: 大麻二酚
lang: CN
name: Cannabidiol
lang: EN
Clinical trial NCT03278782: Study of Pembrolizumab (MK-3475) in Combination With Romidepsin
Official title: A Phase I/II Study of Pembrolizumab (MK-3475) in Combination With Romidepsin in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Conditions: Recurrent Anaplastic Large Cell Lymphoma
Recurrent Angioimmunoblastic T-Cell Lymphoma
Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
Recurrent Mycosis Fungoides
Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
Refractory Anaplastic Large Cell Lymphoma
Refractory Angioimmunoblastic T-Cell Lymphoma
Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Refractory Mycosis Fungoides
Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
Summary: This phase I/II trial studies the side effects of pembrolizumab and romidepsin and to see how well they work in treating participants with peripheral T-cell lymphoma that has come back or that does not respond to treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and romidepsin may work better than pembrolizumab alone in treating participants with recurrent or refractory peripheral T-cell lymphoma.
Interventions:
description: Given IV
name: Pembrolizumab
other_name: Keytruda
Lambrolizumab
MK-3475
SCH 900475
type: Biological
description: Given IV
name: Romidepsin
other_name: Antibiotic FR 901228
Depsipeptide
FK228
FR901228
Istodax
N-[(3S,4E)-3-Hydroxy-7-mercapto-1-oxo-4-heptenyl]-D-valyl-D-cysteinyl-(2Z)-2-amino-2-butenoyl-L-valine, (4->1) Lactone, Cyclic
type: Drug
Study arms:
design_group_description: Participants receive romidepsin IV over 4 hours on days 1 and 8 or day 8 of cycle 1 and days 1 and 8 of subsequent cycles and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (romidepsin, pembrolizumab)
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 罗米地辛
lang: CN
name: Romidepsin
lang: EN
name: ロミデプシン
lang: JP
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
Clinical trial NCT03625037: First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Official title: A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Conditions: DLBCL
High-grade B-cell Lymphoma (HGBCL)
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
FL
MCL
Small Lymphocytic Lymphoma (SLL)
Marginal Zone Lymphoma (MZL)
Indolent B-cell Non-Hodgkin Lymphoma (iNHL)
Aggressive B-cell Non-Hodgkin Lymphoma (aNHL)
Summary: The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20):
* The dose schedule for epcoritamab
* The side effects seen with epcoritamab
* What the body does with epcoritamab once it is administered
* What epcoritamab does to the body once it is administered
* How well epcoritamab works against relapsed and/or refractory B-cell lymphoma
The trial consists of 3 parts:
* a dose-escalation part (Phase 1, first-in-human [FIH])
* an expansion part (Phase 2a)
* a dose-optimization part (OPT) (Phase 2a)
The trial time for each participant depends on which trial part the participant enters:
* For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
* For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends.
All participants will receive active drug, and no participants will be given placebo.
Interventions:
description: Administered as specified in the treatment arm.
name: Epcoritamab
other_name: DuoBody®-CD3xCD20
EPKINLY™
GEN3013
type: Biological
Study arms:
design_group_description: Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.
design_group_title: Epcoritamab
design_group_type: Experimental
Sponsor: Genmab A/S
Collaborators: AbbVie, Inc.
Drug name mappings:
name: 艾可瑞妥单抗
lang: CN
name: Epcoritamab
lang: EN
name: エプコリタマブ(遺伝子組換え)
lang: JP
Clinical trial NCT06621043: Assessing the Safety and Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in the Treatment of Rett Syndrome (RTT)
Official title: Assessing the Safety and Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in the Treatment of Rett Syndrome (RTT)
Conditions: Rett Syndrome
Summary: This 18-week open-label study examines the effectiveness of Full-Spectrum Medicinal Cannabis Plant Extract containing 0.08% THC (NTI164) in treating Rett syndrome (RTT) in children and young people. The study aims to determine the impact of NTI164 on RTT symptoms over a 16-week treatment period.
Participants will start with a daily dose of 5 mg/kg of NTI164, which will be gradually increased over four weeks until they reach either the maximum tolerated dose or 20 mg/kg per day. They will then maintain this dose for eight weeks. Following this treatment phase, the dosage will be reduced by 5 mg/kg each week for four weeks until treatment concludes.
The effectiveness of the treatment will be assessed using tailored questionnaires that measure changes in the patients' conditions. Additionally, full blood examinations will be conducted at multiple points throughout the study to monitor the effects of the treatment.
Interventions:
description: Full-Spectrum Medicinal Cannabis Plant Extract containing 0.08% THC, administered orally starting with a dose of 5 mg/kg, titrated up to 20 mg/kg based on tolerance, followed by a maintenance phase at the maximum tolerated dose, and concluding with a gradual dose reduction.
name: NTI164
type: Drug
Study arms:
design_group_description: Participants in this arm receive Full-Spectrum Medicinal Cannabis Plant Extract containing 0.08% THC (NTI164), targeted at treating symptoms of Rett syndrome (RTT) in children and young people. The intervention starts with a daily initial dose of 5 mg/kg, which is increased gradually over a four-week up-titration phase to a maximum of 20 mg/kg per day, depending on individual tolerance. Participants then continue at their maximum tolerated dose for eight weeks during the treatment phase. The study concludes with a four-week down-titration phase, where the dosage is reduced by 5 mg/kg each week. The effectiveness of the treatment is monitored through specialized questionnaires and full blood examinations throughout the study duration.
design_group_title: Active NTI164 Arm
design_group_type: Experimental
Sponsor: Fenix Innovation Group Pty, Ltd.
Collaborators: Neurotech International Ltd.
Drug name mappings:
name: NTI-164
lang: EN
Clinical trial NCT06056323: A Study of HB0045 Injection in Patients With Advanced Solid Tumors
Official title: A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0045 in Patients With Advanced Solid Tumors
Conditions: Solid Tumor, Adult
Summary: This is a phase I/II, open-label, multicenter study . During the study, subjects will be evaluated for safety, toxicity, tolerability, PK/PD, immunogenicity, biomarkers, and antitumor activity of HB0045. The phase I study will enroll up to 54 subjects with advanced solid tumors who have progressed on or after standard of care therapy and for whom there is no further treatment available that in the judgement of the patient's physician would be beneficial. One cycle is defined as 21 days.
Interventions:
description: Patients will be assigned to dose regimens in the order of enrollment and receive their assigned fixed dose of HB0045 via intravenous infusion, Q3W.
name: HB0045 Drug Product
other_name: fixed dose combination of two antibodies targeting two different epitopes (N-terminal and catalytic site) of CD73
type: Drug
Study arms:
design_group_description: HB0045 IV every 3 weeks (q3w)
design_group_title: HB0045
design_group_type: Experimental
Sponsor: Shanghai Huaaotai Biopharmaceutical Co., Ltd.
Collaborators: The University of Texas MD Anderson Cancer Center
Dana-Farber Cancer Institute, Inc.
Gabrail Cancer Center Research LLC
Drug name mappings:
name: HB0045
lang: EN
Clinical trial NCT04886167: Dysport Dose-Ranging Treatment of Platysmal Bands
Official title: A Dose-Ranging Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Platysmal Bands
Conditions: Platysma Bands
Summary: This is a double-blinded, dose-ranging study in the US to assess the efficacy, safety, and duration of response of abobotulinumtoxinA for the treatment of moderate to severe platysmal bands.
Interventions:
description: Injection of platysmal bands.
name: AbobotulinumtoxinA
other_name: Dysport
type: Drug
Study arms:
design_group_description: Treatment of platysmal bands using a total of 120 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.025mL (5 U).<br/>At the 14 day visit, an optional touch-up using up to 90 U of abobotulinumtoxinA can be performed. This will involve up to 18 injection sites, with each injection site receiving 0.025mL (5 U).
design_group_title: 120U abobotulinumtoxinA
design_group_type: Active Comparator
design_group_description: Treatment of platysmal bands using a total of 180 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.0375mL (7.5 U).<br/>At the 14 day visit, an optional touch-up using up to 90 U of abobotulinumtoxinA can be performed. This will involve up to 12 injection sites, with each injection site receiving 0.0375mL (7.5 U).
design_group_title: 180U abobotulinumtoxinA
design_group_type: Active Comparator
design_group_description: Treatment of platysmal bands using a total of 240 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.05mL (10 U).<br/>At the 14 day visit, an optional touch-up using up to 120 U of abobotulinumtoxinA can be performed. This will involve up to 12 injection sites, with each injection site receiving 0.05mL (10 U).
design_group_title: 240U abobotulinumtoxinA
design_group_type: Active Comparator
Sponsor: Clinical Testing of Beverly Hills
Collaborators: Galderma Holding SA
Drug name mappings:
name: A型肉毒杆菌毒素（Ipsen Biopharm Ltd）
lang: CN
name: AbobotulinumtoxinA (Ipsen Biopharm Ltd)
lang: EN
Clinical trial NCT00412243: Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients
Official title: Phase I/II Study of Clofarabine Plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)
Conditions: Burkitt's Lymphoma
Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia
Summary: The goal of this clinical research study is to find the highest tolerable dose of the drugs clofarabine and cyclophosphamide that can be given together in the treatment of relapsed or refractory ALL. The safety of the combination treatment will also be studied.
Objectives:
Phase I:
1. To establish toxicities and safety of the proposed combination
2. To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the combination to proceed with the phase II part of the study
Phase II:
3. To establish the efficacy (complete and overall response) of the proposed combination.
4. To analyze pharmacokinetic (PK) and pharmacodynamic (PD) properties of clofarabine as well as the impact on DNA repair of leukemic blasts with the proposed combination.
Interventions:
description: 40 mg/m^2 Daily for 3 Days
name: Clofarabine
other_name: Clolar
Clorarex
type: Drug
description: Beginning dose 200 mg/m^2 every 12 hours for 3 days
name: Cyclophosphamide
other_name: Cytoxan
Neosar
type: Drug
Study arms:
design_group_description: Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days
design_group_title: Clofarabine + Cyclophosphamide
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: Genzyme Corp.
Drug name mappings:
name: 氯法拉滨
lang: CN
name: Clofarabine
lang: EN
name: クロファラビン
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
Clinical trial NCT00458237: Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer
Official title: A Brief Dose Escalation Followed by a Phase 2 Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer
Conditions: Breast Cancer
Summary: 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. RAD001 has been used in patients with severe rheumatoid arthritis, in recipients of solid-organ transplants, healthy volunteers and experiments with animals, and information from those other research studies suggest that this RAD001 may help to stop cancer cells from growing abnormally.
Interventions:
description: Everolimus is being administered orally 7 days per week.
name: Everolimus
other_name: RAD001
type: Drug
description: Trastuzumab is being administered at a dose of 6 mg/kg intravenously once every 21 days.
name: Trastuzumab
other_name: Herceptin
type: Drug
Study arms:
design_group_description: Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
design_group_title: Ph I: Everolimus L1 + Trastuzumab
design_group_type: Experimental
design_group_description: Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
design_group_title: Ph I: Everolimus L2 + Trastuzumab
design_group_type: Experimental
design_group_description: Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
design_group_title: PhII: Everolimus MTD + Trastuzumab
design_group_type: Experimental
Sponsor: Beth Israel Deaconess Medical Center, Inc.
Collaborators: Novartis Pharmaceuticals Corp.
Dana-Farber Cancer Institute, Inc.
Drug name mappings:
name: 曲妥珠单抗
lang: CN
name: Trastuzumab
lang: EN
name: トラスツズマブ（遺伝子組換え）
lang: JP
name: 依维莫司
lang: CN
name: Everolimus
lang: EN
name: エベロリムス
lang: JP