PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00307736: Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer
Official title: A Phase I/II Study of Bevacizumab, Erlotinib and 5-fluorouracil With Concurrent External Beam Radiation Therapy in Locally Advanced Rectal Cancer
Conditions: Rectal Cancer
Adenocarcinoma of the Rectum
Summary: The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and erlotinib when administered in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating(Phase II portion) patients with locally advanced rectal cancer.
Interventions:
description: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
name: 5-fluorouracil
type: Drug
description: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
name: bevacizumab
type: Drug
description: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
name: erlotinib
type: Drug
description: Given on days 1-5 and 8-12
name: External beam radiation therapy (EBRT)
type: Procedure
Study arms:
design_group_description: Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
design_group_title: Chemotherapy and radiation
design_group_type: Experimental
Sponsor: The General Hospital Corp.
Collaborators: Genentech, Inc.
Dana-Farber Cancer Institute, Inc.
Beth Israel Deaconess Medical Center, Inc.
Drug name mappings:
name: 盐酸厄洛替尼
lang: CN
name: Erlotinib Hydrochloride
lang: EN
name: エルロチニブ塩酸塩
lang: JP
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
name: 氟尿嘧啶
lang: CN
name: Fluorouracil
lang: EN
name: フルオロウラシル
lang: JP
Clinical trial NCT06110793: A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer
Official title: A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer
Conditions: Metastatic Breast Cancer
Summary: The purpose of this study is to test whether the combination of lenvatinib, pembrolizumab, and fulvestrant is a safe and effective treatment that causes few or mild side effects in people with ER+/HER2- metastatic breast cancer.
Interventions:
description: 20mg orally PO daily
name: Lenvatinib
type: Drug
description: 400mg IV Q6W
name: Pembrolizuma
type: Drug
description: 500mg IM Q4W
name: Fulvestrant
type: Drug
Study arms:
design_group_description: This is an open-label phase Ib/II trial of lenvatinib (20mg orally PO daily) plus pembrolizumab (400mg IV Q6W) plus fulvestrant (500mg IM Q4W) in patients with unresectable, locally advanced/metastatic ER+/HER2- breast cancer.
design_group_title: Lenvatinib, Pembrolizumab, and Fulvestrant
design_group_type: Experimental
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Merck Sharp & Dohme LLC
Drug name mappings:
name: 氟维司群
lang: CN
name: Fulvestrant
lang: EN
name: フルベストラント
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
name: 甲磺酸仑伐替尼
lang: CN
name: Lenvatinib mesylate
lang: EN
name: レンバチニブメシル酸塩
lang: JP
Clinical trial NCT07288814: Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
Official title: A Single-Arm, Open-Label Ib/II Study of Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma（PTCL）
Conditions: Relapsed or Refractory Peripheral T Cell Lymphoma
Summary: To evaluate the safety of mitoxantrone hydrochloride liposome combined with enlonstobart in the treatment of relapsed or refractory peripheral T-cell lymphoma, to determine the optimal dosage of mitoxantrone hydrochloride liposome within the combination regimen, and to assess the efficacy of the combined therapy.
Interventions:
description: Mitoxantrone hydrochloride liposome: ①Phase Ib：16 mg/m2、20 mg/m2 ，D1，q4w; ②Phase II：RP2D, D1，q4w, Up to 6 cycles<br/>Enlonstobart: 360mg，D1，q4w (The maintenance treatment phase is q3w), Up to 1 year
name: Mitoxantrone Hydrochloride Liposome & Enlonstobart
type: Drug
Study arms:
design_group_title: Mitoxantrone hydrochloride liposome combined with enlonstobart
design_group_type: Experimental
Sponsor: Sun Yat-Sen University Cancer Center
Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.
Drug name mappings:
name: 恩朗苏拜单抗
lang: CN
name: Enlonstobart
lang: EN
name: 盐酸米托蒽醌脂质体
lang: CN
name: Mitoxantrone Hydrochloride liposomal
lang: EN
Clinical trial NCT05674656: Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
Official title: Phase 1/2 Study of Switching to Fixed Dose Combination Dolutegravir/Rilpivirine Among Virologically Suppressed Children, 6 to Less Than 12 Years of Age, Living With HIV-1
Conditions: HIV Infections
Summary: The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA [Ribonucleic Acid] < 50 [cells per milliliter] c/mL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg).
Interventions:
description: Dolutegravir/Rilpivirine will be administered.
name: Dolutegravir/Rilpivirine FDC
other_name: JULUCA
type: Drug
Study arms:
design_group_title: Dolutegravir(DTG)/Rilpivirine (RPV)
design_group_type: Experimental
Sponsor: ViiV Healthcare Ltd.
Collaborators: Janssen Research & Development LLC
Drug name mappings:
name: 多替拉韦利匹韦林
lang: CN
name: Dolutegravir Sodium/Rilpivirine Hydrochloride
lang: EN
name: ドルテグラビルナトリウム/リルピビリン塩酸塩
lang: JP
Clinical trial NCT02022670: Sodium Nitrite to Treat Arterial Aging
Official title: Clinical Translation of Nitrite Therapy to Treat Arterial Aging in Humans
Conditions: Vascular Aging
Summary: The proposed research will determine the effectiveness of nitrite, a naturally occurring compound in the body, for improving the health and function of arteries in middle-aged and older adults. The study also will provide insight into how sodium nitrite therapy improves artery health by determining the physiological mechanisms (biological reasons) involved. Overall, the proposed research will provide important new scientific evidence on the effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases with aging.
Interventions:
description: Sugar pill manufactured to mimic sodium nitrite capsules
name: Placebo
type: Drug
description: 80 mg/d or 160 mg/d
name: Sodium Nitrite
other_name: TV1001
type: Drug
Study arms:
design_group_description: inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: 80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
design_group_title: Sodium Nitrite 80 mg/d
design_group_type: Experimental
design_group_description: 160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
design_group_title: Sodium Nitrite 160 mg/d
design_group_type: Experimental
Sponsor: University of Colorado Boulder
Collaborators: TheraVasc, Inc.
Drug name mappings:
name: Sodium nitrite
lang: EN
Clinical trial NCT02265731: Study Evaluating Venetoclax in Subjects With Hematological Malignancies
Official title: A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Japanese Subjects With Hematological Malignancies
Conditions: Non-Hodgkin Lymphoma (NHL)
Multiple Myeloma (MM)
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Acute Myeloid Leukemia (AML)
Summary: This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.
Interventions:
description: 75 mg/m2 by IV infusion or subcutaneous dosing
name: azacitadine
type: Drug
description: Step-up doses of venetoclax to the designated cohort dose
name: venetoclax
type: Drug
description: 375 mg/m2 on Week 6
name: rituximab / IDEC-C2B8
type: Drug
description: 500 mg/m2 Week 10 Day 1 and thereafter
name: rituximab / IDEC-C2B8
type: Drug
Study arms:
design_group_description: Step-up doses of venetoclax to the designated cohort dose administered in participants with relapsed or refractory (R/R) Non-Hodgkin lymphoma (NHL) or multiple myeloma (MM)
design_group_title: Arm A (Phase 1)
design_group_type: Experimental
design_group_description: Step-up doses of venetoclax to the designated dose administered in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
design_group_title: Arm B (Phase 1)
design_group_type: Experimental
design_group_description: Step-up doses of venetoclax to the designated dose with the addition of azacitidine administered in participants with acute myeloid leukemia (AML)
design_group_title: Arm C (Phase 1)
design_group_type: Experimental
design_group_description: Step-up doses of venetoclax to the designated dose with the addition of rituximab in participants with R/R CLL
design_group_title: Arm D (Phase 2)
design_group_type: Experimental
Sponsor: AbbVie, Inc.
Collaborators: Genentech, Inc.
Drug name mappings:
name: 维奈克拉
lang: CN
name: Venetoclax
lang: EN
name: ベネトクラクス
lang: JP
name: 利妥昔单抗
lang: CN
name: Rituximab
lang: EN
name: リツキシマブ（遺伝子組換え）
lang: JP
name: 阿扎胞苷
lang: CN
name: Azacitidine
lang: EN
name: アザシチジン
lang: JP
Clinical trial NCT07432633: [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Official title: A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Conditions: Colorectal Cancer
Epithelial Ovarian Cancer
Gastric Cancer
Invasive Lobular Breast Carcinoma
Pancreatic Ductal Adenocarcinoma
Summary: This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of [18F]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
Interventions:
description: positron emission tomography (PET)/computed tomography (CT) imaging
name: [18F]FPyQCP
type: Drug
Study arms:
design_group_description: Each participant will receive [18F]FPyQCP followed by positron emission tomography (PET)/computed tomography (CT) imaging at the PET/CT imaging visit (Visit 2)
design_group_title: [18F]FPyQCP PET/CT
design_group_type: Experimental
Sponsor: Blue Earth Diagnostics Ltd.
Collaborators: Medpace, Inc.
Drug name mappings:
name: [18F]-FPyQCP
lang: EN
Clinical trial NCT04713046: Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers
Official title: A Phase I Clinical Trial Assessing the Safety, Feasibility and Immunologic Correlates of Allogeneic HPV-specific Cluster of Differentiation 4 (CD4)+ T Cells in Advanced HPV16-associated Malignancies
Conditions: HPV 16+ Recurrent or Metastatic Cancer
Summary: In this study, haploidentical relatives of a patient with recurrent or metastatic HPV 16-associated malignancy will be vaccinated with a therapeutic human papillomavirus (HPV) vaccine series to generate HPV-specific leukocytes. The cancer patient with recurrent or metastatic HPV16+ cancer will then be randomized to one of two arms: 1) non-myeloablative allogeneic bone marrow transplant or 2) cluster of differentiation 8 (CD8)-depleted donor lymphocyte infusion.
Interventions:
description: Patients will receive CD8+ T cell-depleted peripheral blood cells at one of three dose levels following cyclophosphamide: 1) 10^6 CD4+ cells/kg; 2) 5 x 10^6 CD4+ cells/kg; or 3) 10^7 CD4+ cells/kg of recipient ideal body weight.
name: CD8 reduced peripheral blood cells taken from related donors vaccinated against HPV16
type: Biological
description: Standard dosing for bone marrow graft (target dose of 4 x 10^8 nucleated cells/kg) and if progression at Day 90, will receive dose level 1 for the CD8-depleted DLI (106 CD4+ cell/kg).
name: Non-myeloablative allogeneic bone marrow transplant from related donors vaccinated against HPV16
type: Biological
Study arms:
design_group_description: non-myeloablative allogeneic bone marrow transplant (BMT) from a haploidentical relative after vaccination with a therapeutic HPV vaccine series.
design_group_title: Allogeneic bone marrow transplant
design_group_type: Experimental
design_group_description: CD8-depleted donor lymphocyte infusion per dose escalation scheme from a haploidentical relative after vaccination with a therapeutic HPV vaccine series.
design_group_title: CD8-depleted donor lymphocyte infusion (DLI) per dose escalation scheme
design_group_type: Experimental
Sponsor: The Sidney Kimmel Comprehensive Cancer Center
Collaborators: Papivax Biotech, Inc.
Drug name mappings:
name: ISA-101
lang: EN
Clinical trial NCT01160354: Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)
Official title: Phase I/II Study of Plerixafor and Clofarabine in Previously Untreated Older (>/=60 Years) Adult Patients With Acute Myelogenous Leukemia (AML) With Two or More Unfavorable Prognostic Factors for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit
Conditions: Acute Myelogenous Leukemia
Summary: The goal of Part 1 of this clinical research study is to learn about the safety of the combination of plerixafor and clofarabine when given to patients with previously untreated AML who are at least 60 years old.
The goal of Part 2 of this study is to learn if the combination of plerixafor and clofarabine can help to control previously untreated AML in patients who are at least 60 years old. Study was closed early and did not progress to Part 2.
Interventions:
description: Starting at 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before a 1 hour (+/- 30 minutes) IV administration of Clofarabine
name: Plerixafor
other_name: Mobozil
type: Drug
description: Fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
name: Clofarabine
other_name: Clofarex
Clolar
type: Drug
Study arms:
design_group_description: Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).<br/>Phase II: Plerixafor at the highest dose tolerated in Phase I.<br/>Plerixafor was dose-escalated in a 3+3 design, starting at 240 mcg/kg, and proceeding to dose levels of 320 mcg/kg, and 400 mcg/kg.
design_group_title: Plerixafor 240 mcg/kg + Clofarabine
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: 普乐沙福
lang: CN
name: Plerixafor
lang: EN
name: プレリキサホル
lang: JP
Clinical trial NCT07281976: A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer
Official title: An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 Monotherapy or in Combination With Albumin-bound Paclitaxel in Patients With Recurrent or Metastatic Triple Negative Breast Cancer
Conditions: Triple Negative Breast Cancer
Summary: This trial is an open-label, multicenter phase Ib/II clinical study to evaluate the efficacy and safety of LBL-024 monotherapy or in combination with albumin-bound paclitaxel in patients with recurrent or metastatic triple negative breast cancer(TNBC).
Interventions:
description: Intravenous infusion.
name: LBL-024 for Injection
other_name: LBL-024
type: Drug
description: Intravenous infusion.
name: albumin-bound Paclitaxel injection
other_name: albumin-bound Paclitaxel
type: Drug
description: Intravenous infusion.
name: Toripalimab Injection
other_name: Toripalimab
type: Drug
Study arms:
design_group_description: Experimental group：<br/>LBL-024 + albumin-bound paclitaxel.<br/>Intravenous infusion.
design_group_title: LBL-024 + albumin-bound paclitaxel
design_group_type: Experimental
design_group_description: control group：<br/>Toripalimab + albumin-bound paclitaxel or albumin-bound paclitaxel.<br/>Intravenous infusion.
design_group_title: Toripalimab + albumin-bound paclitaxel/albumin-bound paclitaxel
design_group_type: Active Comparator
Sponsor: Nanjing Leads Biolabs Co., Ltd.
Collaborators: Third Affiliated Hospital of Nanjing Medical University
Drug name mappings:
name: 白蛋白结合型紫杉醇
lang: CN
name: Albumin-Bound Paclitaxel
lang: EN
name: パクリタキセル(JAN)
lang: JP
name: 奥帕替苏米单抗
lang: CN
name: Opamtistomig
lang: EN
Clinical trial NCT05522192: Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia
Official title: Clinical Study of Venetoclax Combined With Mitoxantrone Liposome in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Conditions: Relapsed or Refractory Acute Myeloid Leukemia
Summary: This study is an open-label, single-arm, phase I/II clinical study. Phase I is a multi-center, dose-escalation study, aiming to explore the maximum tolerated dose (MTD) of venetoclax combined with mitoxantrone liposome in the treatment of relapsed or refractory acute myeloid leukemia (AML), and determine the recommended dose for phase II (RP2D); Phase II is a multi-center, exploratory study, aiming to explore efficacy of venetoclax combined with mitoxantrone liposome in the treatment of relapsed and refractory AML patients, and to explore the differences in the efficacy of this combination therapy with different gene mutations.
Interventions:
description: Phase I: 24mg/m2, 30 mg/m2, 36mg/m2, IV, d1; Phase II: RP2D.
name: Mitoxantrone liposome
other_name: Mitoxantrone Hydrochloride Liposome Injection
type: Drug
description: Phase I/II: 100mg po d1，200mg po d2，400mg po d3-28.
name: Venetoclax
other_name: Venclexta
type: Drug
Study arms:
design_group_description: Phase I<br/>Mitoxantrone liposome<br/>* Level 1: 24mg/m^2, ivgtt, d1;<br/>* Level 2: 30mg/m^2, ivgtt, d1;<br/>* Level 3: 36mg/m^2, ivgtt, d1;<br/>Venetoclax: 100mg po d1, 200mg po d2, 400mg po d3-28.<br/>Every 4 weeks is a cycle, a total of 2 cycles, the first cycle to observe DLT.<br/>Phase II<br/>Mitoxantrone liposome: RP2D<br/>Venetoclax: 100mg po d1, 200mg po d2, 400mg po d3-28.<br/>28 days is a cycle, and a maximum of 6 cycles can be carried out. If the patient achieves CR, CRi or PR, if the patient can tolerate it, it will be used for 6 cycles; if the patient is suitable for transplantation, it can also enter the transplantation path; If the patient was evaluated as NR (no response) after 2 cycles, he could withdraw from the study.
design_group_title: Venetoclax-Mitoxantrone liposome
design_group_type: Experimental
Sponsor: The First Affiliated Hospital of Jinan University
Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.
Drug name mappings:
name: 维奈克拉
lang: CN
name: Venetoclax
lang: EN
name: ベネトクラクス
lang: JP
name: 盐酸米托蒽醌脂质体
lang: CN
name: Mitoxantrone Hydrochloride liposomal
lang: EN
Clinical trial NCT03975907: Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 1)
Official title: Open Label, Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Fully Human Anti-BCMA Chimeric Antibody Receptor Autologous T Cell （CAR T）in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 1)
Conditions: Multiple Myeloma
Summary: This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT053 CAR-BCMA T in patients with relapsed and/or refractory multiple myeloma.
Interventions:
description: The CAR-BCMA T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting BCMA.
name: CAR-BCMA T Cells
type: Biological
Study arms:
design_group_description: Phase I: The subjects are enrolled into 2 dose level cohorts in sequence. Phase II: Single arm
design_group_title: CAR-BCMA T Cells
design_group_type: Experimental
Sponsor: CARsgen Therapeutics Co. Ltd.
Collaborators: Beijing Chao-Yang Hospital
The Third Xiangya Hospital of Central South University
Qilu Hospital of Shandong University
Xinhua Hospital
the First Affiliated Hospital of Sun Yat-Sen University
The First Affiliated Hospital, Zhejiang University Sch of Med
The First Affiliated Hospital of Soochow University
Sun Yat-Sen University
Shanghai Tongji Hospital
Tianjin Medical University General Hospital
The First Affiliated Hospital of Wenzhou Medical College
Peking University People's Hospital
Beijing Hospital of the Ministry of Health
Drug name mappings:
name: 泽沃基奥仑赛
lang: CN
name: Zevorcabtagene Autoleucel
lang: EN
Clinical trial NCT02058017: OPB-51602 in Locally Advanced Nasopharyngeal Carcinoma Prior to Definitive Chemoradiotherapy
Official title: The Signal Transducer and Activator of Transcription (STAT)3 Pathway and the Development of STAT3 Phosphorylation Inhibitors as Cancer Therapy: Lead-In Phase I Dose-Escalating, Open-Label, Non-Randomised Study of A Weekly Regimen OPB-51602 in Advanced Refractory Solid Tumours With Enrichment Cohorts of Nasopharyngeal Carcinoma Followed By A Biomarker Study Evaluating OPB-51602 in Locally Advanced Nasopharyngeal Carcinoma Prior to Definitive Chemoradiotherapy
Conditions: Nasopharyngeal Carcinoma
Summary: This is a lead-in dose escalation study to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), and recommended Phase II dose of OPB-51602 administered on a weekly basis in subjects with advanced malignancies. Using the recommended phase II dose, the efficacy and tolerability of OPB-51602 administered prior to definitive chemoradiotherapy will be evaluated in locally advanced NPC patients. This study's overarching goal is the development of STAT3 inhibitors as a novel class of anti-cancer agents and the optimization of patient selection for STAT3 inhibitor therapy through parallel biomarker studies. This study hopes to establish a therapeutic window for OPB-51602 in solid tumours and will evaluate its potential as a targeted therapy of NPC, since this represents a critical unmet clinical need. The development of predictive and pharmacodynamic biomarkers in tandem with the clinical evaluation of OPB-51602 will be crucial to its therapeutic advancement and will enable an understanding of the genetic contexts of responsiveness and resistance to OPB-51602, which can in turn lead to the development of effective drug combinations to overcome resistance.The study hypothesizes that OPB-51602, a first-in-class STAT3 inhibitor, is efficacious in solid tumours with constitutively activated STAT3, such as NPC.
Interventions:
name: OPB-51602
other_name: OPB-51602 OPB-51602 is an inhibitor of STAT3 phosphorylation developed by Otsuka Pharmaceuticals, Japan.
type: Drug
Study arms:
design_group_description: Part I - This is a lead-in dose-finding, open-label, non-randomised arm of the study: Using a starting dose of 10mg per week, an accelerated dose titration escalation followed by a 3+3 design will be employed until MTD and recommended weekly dose are determined.<br/>Part II - This is a single-centre, open-label non-randomised phase II study evaluating OPB-51602 in stage III-IVB NPC conducted in the window period prior to definitive chemoradiotherapy. Eligible patients will receive OPB-51602 on a weekly basis (Day 1, 8, 15) at the recommended dose determined in part I for a total of 15 days prior to definitive chemoradiotherapy.
design_group_title: Part I & Part II
design_group_type: Experimental
Sponsor: National University Hospital
Collaborators: Otsuka Pharmaceutical Co., Ltd.
Shin Nippon Biomedical Laboratories, Ltd.
Drug name mappings:
name: OPB-51602
lang: EN