Cargando…

Sources of bias for single-arm phase II cancer clinical trials

A phase II trial is conducted to investigate if an experimental therapy is efficacious enough to proceed to a large-scale phase III trial or not. In spite of the fast progress in design and analysis methods, single-arm two-stage design is still the most popular for phase II cancer clinical trials. I...

Descripción completa

Detalles Bibliográficos
Autor principal:	Jung, Sin-Ho
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	AME Publishing Company 2022
Materias:	Review Article on Challenges in Clinical Trials
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9577758/ https://www.ncbi.nlm.nih.gov/pubmed/36267796 http://dx.doi.org/10.21037/atm-21-6808

Ejemplares similares

A Single‐Arm, Phase II Study of Apatinib in Refractory Metastatic Colorectal Cancer
por: Chen, Xiaofeng, et al.
Publicado: (2019)

Pyrotinib combined with trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor 2-positive metastatic breast cancer: a single-arm exploratory phase II trial
por: Xie, Xiao-Feng, et al.
Publicado: (2022)

Single arm, phase two study of low-dose metronomic eribulin in metastatic breast cancer
por: Chalasani, Pavani, et al.
Publicado: (2021)

GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer
por: Perez-Fidalgo, J Alejandro, et al.
Publicado: (2019)

Burosumab Improved Histomorphometric Measures of Osteomalacia in Adults with X‐Linked Hypophosphatemia: A Phase 3, Single‐Arm, International Trial
por: Insogna, Karl L, et al.
Publicado: (2019)

Functional outcomes and quality of life after a 6-month early intervention program for oral cancer survivors: a single-arm clinical trial
por: Chen, Yueh-Hsia, et al.
Publicado: (2018)

Pegylated liposomal doxorubicin (Duomeisu(®)) monotherapy in patients with HER2-negative metastatic breast cancer heavily pretreated with anthracycline and taxanes: a single-arm, phase II study
por: Jiang, Hanfang, et al.
Publicado: (2023)

Apatinib in Combination with S‐1 as First‐Line Treatment in Patients with Advanced Metastatic Gastric Cancer: Results from an Open, Exploratory, Single‐Arm, Phase II Trial
por: Zhou, Na, et al.
Publicado: (2020)

Famitinib with Camrelizumab and Nab-Paclitaxel for Advanced Immunomodulatory Triple-Negative Breast Cancer (FUTURE-C-Plus): An Open-Label, Single-Arm, Phase II Trial
por: Chen, Li, et al.
Publicado: (2022)

Ramucirumab Plus Docetaxel for Patients with Non-small cell Lung Cancer with Brain Metastases: A Multicenter, Open-Label Single-Arm Phase II Trial
por: Tanimura, Keiko, et al.
Publicado: (2023)

Phase II Single-Arm Study of Palbociclib and Cetuximab Rechallenge in Patients with KRAS/NRAS/BRAF Wild-Type Colorectal Cancer
por: Sorah, Jonathan D, et al.
Publicado: (2022)

A randomized, phase II, three-arm study of two schedules of ixabepilone or paclitaxel plus bevacizumab as first-line therapy for metastatic breast cancer
por: Rugo, Hope S., et al.
Publicado: (2013)

Neoadjuvant carboplatin in triple-negative breast cancer: results from NACATRINE, a randomized phase II clinical trial
por: de Pádua Souza, Cristiano, et al.
Publicado: (2023)

A flexible design for advanced Phase I/II clinical trials with continuous efficacy endpoints
por: Mozgunov, Pavel, et al.
Publicado: (2019)

A single-arm phase II study of olaparib maintenance with pembrolizumab and bevacizumab in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer (OPEB-01)
por: Lee, Yong Jae, et al.
Publicado: (2021)

Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial
por: Zhang, Zhanjie, et al.
Publicado: (2022)

OncoVee™-MiniPDX-guided anticancer treatment for HER2-negative intermediate-advanced gastric cancer patients: a single-arm, open-label phase I clinical study
por: Zhang, Baonan, et al.
Publicado: (2023)

Single Arm, Phase II Study of Cisplatin, Docetaxel, and Erlotinib in Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas
por: William, William N., et al.
Publicado: (2018)

An open-label, single-arm phase 2 trial of valemetostat for relapsed or refractory adult T-cell leukemia/lymphoma
por: Izutsu, Koji, et al.
Publicado: (2023)

Efficacy and Safety of First-Generation EGFR-TKIs Combined with Chemotherapy for Treatment-Naïve Advanced Non-Small-Cell Lung Cancer Patients Harboring Sensitive EGFR Mutations: A Single-Center, Open-Label, Single-Arm, Phase II Clinical Trial
por: Lin, Jinghui, et al.
Publicado: (2021)

Atezolizumab plus Bevacizumab in Patients with Unresectable or Metastatic Mucosal Melanoma: A Multicenter, Open-Label, Single-Arm Phase II Study
por: Mao, Lili, et al.
Publicado: (2022)

A Phase II Trial of Sorafenib in Metastatic Melanoma with Tissue Correlates
por: Ott, Patrick A., et al.
Publicado: (2010)

Intercalated combination of chemotherapy and erlotinib for stage IIIA non-small-cell lung cancer: a multicenter, open-label, single-arm, phase II study
por: Chen, Zhiwei, et al.
Publicado: (2019)

Subcutaneous trastuzumab with pertuzumab and docetaxel in HER2-positive metastatic breast cancer: Final analysis of MetaPHER, a phase IIIb single-arm safety study
por: Kuemmel, Sherko, et al.
Publicado: (2021)

The Oral PI3Kδ Inhibitor Linperlisib for the Treatment of Relapsed and/or Refractory Follicular Lymphoma: A Phase II, Single-Arm, Open-Label Clinical Trial
por: Wang, Tingyu, et al.
Publicado: (2023)

A single-arm, phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive, recurrent ovarian cancer patients previously treated with a PARP inhibitor: Korean Gynecologic Oncology Group (KGOG 3056)/NIRVANA-R trial
por: Park, Junsik, et al.
Publicado: (2021)

Apatinib in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma: A Phase II, Open-Label, Single-Arm, Prospective Study
por: Ma, Xinran, et al.
Publicado: (2020)

Seraprevir and sofosbuvir for treatment of chronic hepatitis C virus infection: A single‐arm, open‐label, phase 3 trial
por: Kong, Fei, et al.
Publicado: (2021)

Prospective, randomized, single-blinded, multi-center phase II trial of two HER2 peptide vaccines, GP2 and AE37, in breast cancer patients to prevent recurrence
por: Brown, Tommy A., et al.
Publicado: (2020)

Erlotinib as Neoadjuvant Therapy in Stage IIIA (N2) EGFR Mutation‐Positive Non‐Small Cell Lung Cancer: A Prospective, Single‐Arm, Phase II Study
por: Xiong, Liwen, et al.
Publicado: (2018)

Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer
por: Chung, Moon Jae, et al.
Publicado: (2018)

Novel clinical trial design and analytic methods to tackle challenges in therapeutic development in rare diseases
por: Li, Yimei, et al.
Publicado: (2022)

A phase II multi-arm study of magrolimab combinations in patients with relapsed/refractory multiple myeloma
por: Paul, Barry, et al.
Publicado: (2023)

Eribulin-based neoadjuvant chemotherapy for triple-negative breast cancer patients stratified by homologous recombination deficiency status: a multicenter randomized phase II clinical trial
por: Masuda, Norikazu, et al.
Publicado: (2021)

A Phase II Clinical Trial of Nivolumab and Temozolomide for Neuroendocrine Neoplasms
por: Owen, Dwight H., et al.
Publicado: (2023)

Unremitting Suicidality in Borderline Personality Disorder: A Single Case Study and Discussion of Technology in Clinical Care
por: Choi-Kain, Lois W., et al.
Publicado: (2022)

Efficacy and Safety of Apatinib for Elderly Patients with Advanced or Metastatic Gastric Cancer After Failure of at Least First-Line Chemotherapy: A Multi-Center, Single-Arm, Phase II Study
por: Ren, Dengfeng, et al.
Publicado: (2021)

Exploratory Phase II Multicenter, Open-Label, Clinical Trial of ST266, a Novel Secretome for Treatment of Persistent Corneal Epithelial Defects
por: Jeng, Bennie H., et al.
Publicado: (2022)

A phase II trial to assess efficacy and safety of afatinib in extensively pretreated patients with HER2-negative metastatic breast cancer
por: Schuler, Martin, et al.
Publicado: (2012)

Safety and Efficacy of Bis-Glyceryl Ascorbate as Prophylaxis for Hand-Foot Skin Reaction: A Single-Arm, Open-Label Phase I/II Study (DGA Study)
por: Yamamoto, Kazuhiro, et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_m0f6mpl7elp73qr65tp83h72q4