PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03844750: Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases
Official title: A Phase II Study of Preoperative Immunotherapy in Patients With Colorectal Cancer and Resectable Hepatic Metastases
Conditions: Metastatic Malignant Neoplasm in the Liver
Stage IV Colorectal Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8
Summary: This phase II trials studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer that has spread to the liver that can be removed by surgery (resectable hepatic metastases). 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. Vactosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and vactosertib after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. This study also investigates pembrolizumab and vactosertib after liver metastases surgery, decrease the risk of the cancer recurring (coming back).
Interventions:
description: Undergo liver resection.
name: Hepatectomy
other_name: Liver Resection
type: Procedure
description: Given IV
name: Pembrolizumab
other_name: Keytruda
Lambrolizumab
MK-3475
SCH 900475
type: Biological
description: Given orally
name: Vactosertib
other_name: EW-7197
type: Drug
Study arms:
design_group_description: Neoadjuvant pembrolizumab will be administered at a fixed dose of 200 mg (IV) for 1 cycle plus 200 mg vactosertib (PO QD, 5 days per week x 2 weeks). Adjuvant pembrolizumab (400 mg IV) + vactosertib (200 mg PO QD Cycle 1, 5 days per week, Cycles 2 and beyond (200 mg BID, 5 days per week) will be administered for up to eight 6-week cycles
design_group_title: Treatment (vactosertib, pembrolizumab, surgery)
design_group_type: Experimental
Sponsor: The University of California, San Francisco
Collaborators: MedPacto, Inc.
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: Vactosertib
lang: EN
Clinical trial NCT05695378: Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy (MSA)
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy
Conditions: Multiple System Atrophy
Summary: This trial will the efficacy of KM-819 compared to placebo in subjects with MSA for slowing the progression of MSA.
Interventions:
description: Subjects will receive KM-819 400 mg orally daily.
name: KM-819
type: Drug
description: Subjects will receive Placebo orally daily.
name: Placebo
type: Drug
Study arms:
design_group_description: Subjects will receive 400 mg of KM-819 orally from Week 0 to Week 36.
design_group_title: Main Study: KM-819
design_group_type: Experimental
design_group_description: Subjects will receive visually identical placebo pills of KM-819 orally.
design_group_title: Main Study: Placebo
design_group_type: Placebo Comparator
design_group_description: Subjects will receive 400 mg of KM-819 orally from Week 40 to Week 76.
design_group_title: Ancillary Study: KM-819
design_group_type: Experimental
Sponsor: Kainos Medicine, Inc.
Collaborators: PAREXEL International Corp.
Drug name mappings:
name: KM-819
lang: EN
Clinical trial NCT05576480: SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer
Official title: Efficacy and Safety of Short-course Radiotherapy Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of Microsatellite Stable Locally Advanced Rectal Cancer: a Single-centre, Single-arm, Phase 2 Study
Conditions: Rectal Cancer
Locally Advanced
Summary: The goal of this phase 2 study is to learn about the efficacy and safety of short-course radiotherapy (SCRT) sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable (MSS) locally advanced rectal cancer. The main question it aims to answer is the role of immune checkpoint inhibitors in the neoadjuvant treatment of MSS rectal cancer. Participants will receive neoadjuvant treatment of SCRT sequential Penpulimab in combination with CAPEOX. Participants will undergo a clinical re-staging assessment at the end of neoadjuvant therapy to determine whether to adopt a watch-and-wait strategy or undergo radical surgery.
Interventions:
description: 5×5Gy in Week 1
name: Short-course radiotherapy
type: Radiation
description: Apply once in the first week, then every 3 weeks from the third week for four cycles
name: Penpulimab
other_name: PD-1 monoclonal antibody
type: Drug
description: Apply every 3 weeks from week 3 for 4 cycles
name: CAPEOX
other_name: Capecitabine and oxaliplatin
type: Drug
description: Patient will receive radical rectal cancer surgery
name: TME surgery
type: Procedure
Study arms:
design_group_description: * Short-course radiotherapy (SCRT) + one dose of immunotherapy in week 1：Radiotherapy once daily at 5Gy, D1-D5 (5×5Gy); Penpulimab, 200mg, intravenous for 60±5min, D6 or D7.<br/>* Rest at week 2, 4 cycles of chemotherapy (CAPEOX) + immunotherapy from week 3 in cycles of 3 weeks: Capecitabine, 1000 mg/m2 orally, administered twice daily, D1-D14 per cycle; Oxaliplatin, 135 mg/m2, intravenous >2h, administered every cycle D1; Penpulimab, 200 mg, administered intravenously for 60 ± 5 min every cycle D1.<br/>* Clinical re-staging assessment at the end of neoadjuvant therapy allows for a watch-and-wait strategy if cCR is achieved. If any residual lesions remained, radical rectal cancer surgery would be performed at least 2 weeks after the last dose of capecitabine. Whether post-operative adjuvant treatment is performed and the option of post-operative adjuvant treatment is decided by the investigator.
design_group_title: SCRT sequential Penpulimab in combination with CAPEOX
design_group_type: Experimental
Sponsor: Ruijin Hospital
Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Drug name mappings:
name: 派安普利单抗
lang: CN
name: Penpulimab
lang: EN
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP
name: 卡培他滨
lang: CN
name: Capecitabine
lang: EN
name: カペシタビン
lang: JP
Clinical trial NCT02903446: Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions
Official title: Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions in Gout: A Pilot Study
Conditions: Gout
Summary: Bone erosions are a common manifestation and feature of structural damage in severe/chronic tophaceous gout. Management of this destructive and often debilitating gout complication has focused exclusively on urate-lowering therapy (ULT) to reduce frequency of gout attacks, but little attention has been given to prevention or reversal of gout related bone erosions and other structural damage to bone caused by gout. Since there is no known effective treatment to attenuate or improve structural damage caused by gout, we propose a pilot, controlled, proof-of-concept study in which denosumab, an FDA approved medication for the treatment of bone loss, will be added to standard ULT in 20 patients with erosive gout.
Interventions:
description: Participants will be randomized (1:1) allocation to denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + ULT standard of care OR ULT standard of care therapy
name: Denosumab
other_name: Prolia
type: Drug
Study arms:
design_group_description: Denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + urate lowering therapy (ULT) standard of care
design_group_title: Intervention
design_group_type: Active Comparator
design_group_description: Standard urate lowering therapy
design_group_title: Control
design_group_type: No Intervention
Sponsor: The University of Alabama at Birmingham
Collaborators: Auckland University
Drug name mappings:
name: 地舒单抗
lang: CN
name: Denosumab
lang: EN
name: デノスマブ（遺伝子組換え）
lang: JP
Clinical trial NCT04656951: Daratumumab for First Line Treatment of Transplant-ineligible Myeloma Patients Followed by Daratumumab Re-treatment at First Relapse
Official title: Daratumumab for First Line Treatment of Transplant-ineligible Myeloma Patients Followed by Daratumumab Re-treatment at First Relapse
Conditions: Multiple Myeloma
Summary: Daratumumab for first line treatment of transplant-ineligible myeloma patients followed by daratumumab re-treatment at first relapse (GMMG-DADA)
Interventions:
description: Daratumumab added to induction regimen of bortezomib, cyclophosphamide and dexamethasone (VCD), to bortezomib and dexamethasone during maintenance and to lenalidomide and dexamethasone at progression/relapse.
name: Daratumumab
other_name: Darzalex
type: Drug
Study arms:
design_group_description: Daratumumab at standard dose of 1800 mg will be administered subcutaneously at weekly intervals in cycles 1-2 and every 2 weeks in cycles 3-6 and every 4 weeks in cycles 7-8 together with VCD using bortezomib weekly s.c. for 8 cycles of 28 days each, cyclophosphamide i.v. at 500 mg/m2 on d1 of every cycle and dexamethasone p.o. at 20 mg per week.<br/>Maintenance will be daratumumab subcutaneously every 4 weeks with bortezomib s.c. and dexamethasone 20 mg every 2 weeks until progression or intolerance.<br/>At relapse/progression treatment will be daratumumab 1800 mg subcutaneously weekly during cycle 1-2, every 2 weeks in cycle 3-6 and every 4 weeks thereafter together with lenalidomide 25 mg p.o. day 1-21 and dexamethasone 20-40 mg weekly.
design_group_title: Daratumumab added to VCd in induction, Vd in maintenance and Rd at relapse
design_group_type: Experimental
Sponsor: University of Cologne Executive School GmbH
Collaborators: Janssen-Cilag GmbH
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
Clinical trial NCT03310632: Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer
Official title: A Phase I/II Study to Determine the MTD and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer
Conditions: Pancreatic Neoplasm
Summary: Antroquinonol is proposed for the treatment of neoplasms. The proposed clinical trial is a Phase I/II study designed to evaluate antroquinonol in combination with nab-paclitaxel and gemcitabine in first line treatment naïve subjects with Stage IV metastatic pancreatic carcinoma. The first part of study will focus on the treatment of pancreatic cancer with 200 mg TID and 300 mg TID, clinical treatment duration of 4 weeks, to determine the MTD or MFD (based on PK and capsules strength) of antroquinonol in combination with a standard dose regimen of nab-paclitaxel and gemcitabine. The extended Phase II will focus on the efficacy of antroquinonol with SOC. Safety and pharmacokinetic profiles will be studied in the proposed clinical trial.
Interventions:
description: Antroquinonol: 100 mg and corn oil 100 mg encapsulated in a gelatin capsule administered orally. Dose will be selected(200mg TID or 300mg TID with SOC) after phase I, then follow up the best dose for 40 Patients for the efficacy.
name: Antroquinonol
other_name: Hocena
type: Drug
Study arms:
design_group_description: Antroquinonol will first be conducted by dose escalation(200mg TID and 300mgTID) to characterize the safety of antroquinonol in combination with the standard of care (SOC) (nab-paclitaxel + gemcitabine) and to identify the MTD of antroquinonol in patients with metastatic pancreatic cancer.<br/>At the cohort expansion part of the study, up to an additional 40 patients will be enrolled at the MTD or MFD/RD.
design_group_title: Antroquinonol with SOC
design_group_type: Experimental
Sponsor: Golden Biotechnology Corporation
Collaborators: Labcorp Drug Development, Inc.
Drug name mappings:
name: 安卓奎诺尔
lang: CN
name: Antroquinonol
lang: EN
Clinical trial NCT00855062: Minocycline for HIV+ Cognitive Impairment in Uganda
Official title: Minocycline in the Treatment of HIV-Associated Cognitive Impairment in Uganda
Conditions: HIV-associated Cognitive Impairment
HIV Infections
Summary: Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of Human immunodeficiency virus (HIV)-associated cognitive impairment in Uganda.
Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with Optional 24-week Open Label Phase for Subjects with a cluster of differentiation 4 (CD4) Count in the 251-350 Range
* Arm 1: Minocycline 100 mg orally every 12 hours (50 subjects)
* Arm 2: Matching placebo orally every 12 hours (50 subjects)
Primary Objective:
· To examine whether minocycline treatment will improve cognitive performance after 24 weeks compared to baseline
Secondary Objectives:
* To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
* To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
* To examine whether minocycline treatment for 24 weeks improves functional impairment
Interventions:
description: 100 mg capsule every 12 hours by mouth
name: minocycline
type: Drug
description: 1 capsule every 12 hours by mouth
name: minocycline placebo capsule
type: Drug
Study arms:
design_group_description: Minocycline 100 mg orally every 12 hours
design_group_title: Minocycline
design_group_type: Active Comparator
design_group_description: Placebo minocycline capsules every 12 hours
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The Johns Hopkins University
Collaborators: Makerere University
Drug name mappings:
name: 盐酸米诺环素
lang: CN
name: Minocycline Hydrochloride
lang: EN
name: ミノサイクリン塩酸塩
lang: JP
Clinical trial NCT03833206: A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients
Official title: A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients: Part I Dose Escalation
Conditions: Major Depressive Disorder
Summary: The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.
Interventions:
description: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
name: PDC-1421 Capsule
type: Drug
Study arms:
design_group_description: 1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
design_group_title: 1 PDC-1421 Capsule
design_group_type: Experimental
design_group_description: 2 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
design_group_title: 2 PDC-1421 Capsules
design_group_type: Experimental
Sponsor: BioLite, Inc.
Collaborators: American BriVision Corp.
Drug name mappings:
name: BLI-1008
lang: EN
Clinical trial NCT04194554: A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
Official title: A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate Cancer
Conditions: Prostate Cancer
Summary: The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (the phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (the phase 2 portion of the study).
Interventions:
description: given PO per dose escalation schedule
name: Niraparib
type: Drug
description: 22.5 mg q3 month
name: Leuprolide
type: Drug
description: 1000 mg daily
name: Abiraterone Acetate
type: Drug
description: 5-6 fraction SBRT (total dose: 37.5-40 Gy)
name: Stereotactic body radiotherapy (SBRT)
other_name: Ultra-hypofractionated radiotherapy
type: Radiation
Study arms:
design_group_description: Dose Level 1: 100 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT<br/>Dose Level 2: 200 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT<br/>Dose Level 3: 200 mg PO daily of Niraparib without breaks during SBRT until completion of 6 cycles.
design_group_title: Niraparid Dose Escalation
design_group_type: Experimental
Sponsor: Rogel Cancer Center: University of Michigan
Collaborators: Janssen Scientific Affairs LLC
Drug name mappings:
name: 醋酸阿比特龙
lang: CN
name: Abiraterone acetate
lang: EN
name: アビラテロン酢酸エステル
lang: JP
name: 甲苯磺酸尼拉帕利
lang: CN
name: Niraparib Tosylate
lang: EN
name: ニラパリブトシル酸塩水和物
lang: JP
name: 醋酸亮丙瑞林
lang: CN
name: Leuprolide Acetate
lang: EN
name: リュープロレリン酢酸塩
lang: JP
Clinical trial NCT01271504: E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma
Official title: An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Patients With Hepatocellular Carcinoma
Conditions: Hepatocellular Carcinoma
Summary: The purpose of this study is to determine whether patients with hepatocellular carcinoma who receive either E7050 administered with Sorafenib or Sorafenib alone experience greater benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.
Interventions:
description: Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib
name: Sorafenib
type: Drug
description: E7050 given orally at 200, 300 or 400 mg once daily.<br/>Sorafenib given orally, 400 mg twice daily.
name: Sorafenib
type: Drug
Study arms:
design_group_description: Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib
design_group_title: Phase Ib: Cohort 1,2, and 3
design_group_type: Active Comparator
design_group_description: Phase II: Arm 1; E7050 + 400 mg Sorafenib Arm 2; 400 mg Sorafenib
design_group_title: Phase II: Arm 1; E7050 + Sorafenib
design_group_type: Active Comparator
Sponsor: Eisai, Inc.
Collaborators: PharmaBio Development, Inc.
Drug name mappings:
name: 甲苯磺酸索拉非尼
lang: CN
name: Sorafenib Tosylate
lang: EN
name: ソラフェニブトシル酸塩
lang: JP
Clinical trial NCT03838042: INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies
Official title: INFORM2 Exploratory Multinational Phase I/II Combination Study of Nivolumab and Entinostat in Children and Adolescents With Refractory High-risk Malignancies (INFORM2-NivEnt)
Conditions: CNS Tumor
Solid Tumor
Summary: The aim of this trial is to determine preliminary activity of the combination treatment with nivolumab and entinostat in children and adolescents with high risk refractory/relapsed/progressive tumors harboring a high mutational load, focal MYC(N) amplification or ATRT-MYC subgroup as well as tumors with high tumor infiltrating lymphocytes (TILs) or a tertiary lymphoid structure (TLS).
Interventions:
description: Patients entering phase I will receive one week entinostat without nivolumab (priming phase) before receiving the combination treatment of nivolumab and entinostat.
name: Nivolumab and Entinostat
other_name: Opdivo
type: Drug
Study arms:
design_group_description: Combination Study of Nivolumab and Entinostat
design_group_title: Nivolumab and Entinostat
design_group_type: Experimental
Sponsor: University Hospital Heidelberg
Collaborators: German Cancer Research Center
Drug name mappings:
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
Clinical trial NCT04669067: TL-895 and KRT-232 Study in Acute Myeloid Leukemia
Official title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With KRT-232 in Patients With Relapsed/Refractory (R/R) FLT3+ Acute Myeloid Leukemia (AML)
Conditions: Acute Myeloid Leukemia
Summary: This study evaluates TL-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with navtemadlin (KRT-232), a novel oral small molecule inhibitor of MDM2 for the treatment of adults with FLT3 mutated Acute Myeloid Leukemia. Participants must be relapsed/refractory (e.g., having failed prior therapy) to be eligible for this study.
Interventions:
description: TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
name: TL-895
type: Drug
description: KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
name: KRT-232
type: Drug
Study arms:
design_group_description: KRT-232 240mg QD, orally administered on days 1 through 7 of each 28-day cycle in combination with TL-895 150mg BID continuously for each 28-day cycle.
design_group_title: Phase 1b - Dose Level 1
design_group_type: Experimental
design_group_description: KRT-232 300mg QD, orally administered on days 1 through 7 of each 28-day cycle in combination with TL-895 150mg BID continuously for each 28-day cycle.
design_group_title: Phase 1b - Dose Level 2
design_group_type: Experimental
design_group_description: Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 150 mg BID continuously for the first 28-day cycle<br/>Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 150 mg BID continuously for each 28-day cycle.
design_group_title: Phase 1b - Dose Level 3
design_group_type: Experimental
design_group_description: Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 300 mg BID continuously for the first 28-day cycle.<br/>Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 300 mg BID continuously for each 28-day cycle.
design_group_title: Phase 1b - Dose Level 4
design_group_type: Experimental
design_group_description: Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 450 mg BID continuously for the first 28-day cycle.<br/>Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 450 mg BID continuously for each 28-day cycle.
design_group_title: Phase 1b - Dose Level 5
design_group_type: Experimental
design_group_description: Dose expansion of the recommended phase 2 dose of TL-895 in combination with KRT-232 as determined in Phase 1b.
design_group_title: Phase 2 - Dose Expansion
design_group_type: Experimental
Sponsor: Telios Pharmaceuticals, Inc.
Collaborators: Kartos Therapeutics, Inc.
Drug name mappings:
name: Navtemadlin
lang: EN
name: M-7583
lang: EN