Preface to the themed issue on ‘Early phase clinical trial design methodology’

2019 ◽  
Vol 68 (2) ◽  
pp. 267-269
Author(s):  
Nolan A. Wages ◽  
Ying Yuan
Keyword(s):  
Clinical Trial ◽  
Early Phase ◽  
Trial Design ◽  
Design Methodology ◽  
Clinical Trial Design ◽  
Early Phase Clinical Trial ◽  
Phase Clinical Trial

scholarly journals Tailoring early-phase clinical trial design to address multiple research objectives

2019 ◽  
Vol 69 (1) ◽  
pp. 95-102 ◽  
Author(s):  
Nolan A. Wages ◽  
Craig L. Slingluff ◽  
Timothy N. Bullock ◽  
Gina R. Petroni
Keyword(s):  
Clinical Trial ◽  
Early Phase ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Early Phase Clinical Trial ◽  
Phase Clinical Trial

scholarly journals Novel Early Phase Clinical Trial Design in Oncology

2017 ◽  
Vol 31 (5) ◽  
pp. 297-307
Author(s):  
Ciara O’Brien ◽  
Louise Carter ◽  
Natalie Cook ◽  
Emma Dean
Keyword(s):  
Clinical Trial ◽  
Early Phase ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Early Phase Clinical Trial ◽  
Phase Clinical Trial

scholarly journals PATH-08. THE IVY GLIOBLASTOMA PATIENT ATLAS - A NOVEL CLINICAL AND RADIO-GENOMICS RESOURCE FOR EARLY PHASE CLINICAL TRIAL DESIGN AND INTERPRETATION

2018 ◽  
Vol 20 (suppl_6) ◽  
pp. vi159-vi159
Author(s):  
Keith Ligon ◽  
Janine Lupo ◽  
Annette Molinaro ◽  
Shannon Block ◽  
Sarah Charbonneau ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Early Phase ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Glioblastoma Patient ◽  
Early Phase Clinical Trial ◽  
Phase Clinical Trial

Compliance with dietary guidelines and its relationship with symptoms and clinical outcomes in patients with advanced cancer in early-phase oncology clinical trials.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 199-199
Author(s):  
Goldy George ◽  
Alan J Kim ◽  
Melat Gebremeskel ◽  
Meryna Manandhar ◽  
Harsha M Pradeep ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Advanced Cancer ◽  
Early Phase ◽  
Symptom Burden ◽  
Whole Grains ◽  
Dietary Guidelines ◽  
Early Phase Clinical Trial ◽  
Dietary Guidelines For Americans ◽  
Phase Clinical Trial

199 Background: We examined compliance with the Dietary Guidelines for Americans and its association with symptom burden and clinical outcomes in patients with advanced cancer in early-phase clinical trials testing novel immunotherapeutic and targeted agents. Methods: Patients starting an early-phase clinical trial (ECOG-PS = 0-1) were recruited into a prospective, longitudinal design with assessments at baseline and at the end of Cycle 1. Diet and symptom burden were assessed using the validated National Cancer Institute Diet History Questionnaire (NCI-DHQ) and the MD Anderson Symptom Inventory, respectively. Compliance with the Dietary Guidelines for Americans recommendations was measured via the Healthy Eating Index (HEI) (a measure of dietary intake per total energy), computed from NCI-DHQ food group and nutrient scores; higher HEI scores indicate greater compliance with dietary guidance recommendations (possible range = 0–100). Statistical tests included Spearman rank correlations (rho), and Cox proportional hazards models. Results: Among early-phase clinical trial patients [N = 40; 50% female; 80% Non-Hispanic White; 80% ECOG = 1; 36% on trials including an immunotherapeutic agent and 64% on targeted therapy trials; mean age = 55y; mean BMI = 28], mean HEI was 69, compared to 59 for the US general population. The proportion of phase I clinical trial patients who met adequacy guidelines were 80% for whole fruit, 73% for total protein foods, 55% for seafood and plant proteins, 55% for total fruit, 50% for greens and beans, 28% for total vegetables, 15% for fatty acids [(PUFAs + MUFAs)/SFAs ≥2.5], 13% for dairy, and 0% for whole grains. The proportion of patients who met moderation guidelines were 28% for refined grains, 28% for added sugar, 13% for saturated fat, and 0% for sodium. Female patients had higher HEI scores than male patients (73 vs. 65, P = 0.004). Patients who were normal weight (BMI < 25) had higher scores for meeting the moderation in sugar intake guideline than overweight patients (BMI≥25) (7.7 vs. 5.5, P = 0.031). Higher intakes of cooked lean meat from beef, pork, veal, lamb, and game were linked to prolonged overall survival (HR = 0.5, 95%CI = 0.26, 0.96, P = 0.039). In immunotherapy patients, greater compliance with seafood and plant protein recommendations was associated with less fatigue at end of Cycle 1 (rho = -0.7, P = 0.008); in targeted therapy patients, higher glycemic load was associated with worse pain (rho = 0.7, P = 0.004). Conclusions: Diets of these early-phase clinical trial patients overall were congruent with recommendations in the Dietary Guidelines for Americans. However, increasing intakes of whole grains and reducing sodium intakes may be useful dietary goals for this population. Also, dietary factors may influence symptoms, such as fatigue and pain, in early-phase clinical trial patients with advanced cancer.

scholarly journals Molecular profiling of metastatic bladder cancer early-phase clinical trial participants predicts patient outcomes

2020 ◽  
pp. molcanres.0751.2020
Author(s):  
Omar Alhalabi ◽  
Andrew W Hahn ◽  
Pavlos Msaouel ◽  
Alexander Y Andreev-Drakhlin ◽  
Funda Meric-Bernstam ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bladder Cancer ◽  
Patient Outcomes ◽  
Early Phase ◽  
Molecular Profiling ◽  
Early Phase Clinical Trial ◽  
Metastatic Bladder Cancer ◽  
Phase Clinical Trial ◽  
Trial Participants

Effective targeted antitumor activity of the antimicrobial agent taurolidine against relapsed/refractory neuroblastoma: Cytotoxicity, target modulation and tumor xenograft studies.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21502-e21502
Author(s):  
Lucy Swift ◽  
Chunfen Zhang ◽  
Antony Pfaffle ◽  
Paul Chew ◽  
Olga Kovalchuk ◽  
...  
Keyword(s):  
Gene Expression ◽  
Clinical Trial ◽  
Early Phase ◽  
Phase Contrast ◽  
Time Lapse ◽  
Early Phase Clinical Trial ◽  
Phase Clinical Trial ◽  
Time Lapse Video

e21502 Background: Neuroblastoma (NB) is the most common extracranial solid tumor and one of the most complex and difficult to treat diseases in pediatrics. Currently, even with highly aggressive treatment protocols, the prognosis for patients with high-risk and relapsed NB remains poor. Hence, there is a clear need to identify new agents and novel therapeutic strategies for the treatment of these children. Taurolidine (TRD) is derived from the aminosulfoacid taurine and has known anti-microbial and anti-inflammatory properties. TRD has demonstrated anti-neoplastic activity against a range of aggressive human tumors. We present mechanistic evidence and supportive preclinical data from in vitro and animal models of refractory NB for the development of an early phase clinical trial incorporating TRD. Methods: For in vitro activity studies, a panel of cell lines derived from patients with relapsed NB (n = 6) and normal control cells were treated with increasing concentrations of TRD and cell viability was measured by alamar blue assay. Phase-contrast light microscopy, western blotting, time-lapse video microscopy and analysis of global gene expression by RNA-Seq were used to evaluate target modulation and induction of cell death pathways. Bioluminescence imaging of mice bearing NB xenografts treated with TRD was used to investigate the efficacy of TRD in vivo. Results: Cell survival data showed that TRD is cytotoxic against NB cell lines in vitro (mean IC50 value 100 µM, range 65-135 µM). Phase-contrast and time-lapse video microscopy confirmed the antitumor effects of TRD. Western blot analyses identified that TRD induced target modulation and an effective apoptotic cascade, resulting in PARP cleavage. Gene expression analyses and signaling pathway activation scores indicated alterations in the Notch, MAPK and IL-10 signaling pathways. Xenograft studies further validated the in vivo activity of TRD with decreased tumor burden in treated mice and a measurable improvement in survival. Conclusions: Our study provides key pre-clinical data on the activity and mechanism of action of TRD against NB. The findings support the rationale for further evaluation of TRD for the treatment of relapsed/refractory NB patients in an early phase clinical trial.

scholarly journals Clinical benefit of early phase clinical trial participation for advanced sarcoma patients

2010 ◽  
Vol 68 (2) ◽  
pp. 423-429 ◽  
Author(s):  
Robin L. Jones ◽  
David Olmos ◽  
Khin Thway ◽  
Cyril Fisher ◽  
Nina Tunariu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Benefit ◽  
Early Phase ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Early Phase Clinical Trial ◽  
Phase Clinical Trial ◽  
Advanced Sarcoma
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