Toga trial doses


















TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. The median time, in months, from the date of randomized to the date of a TTP event.

Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted.

The median time, in months, of the duration of response. The participant assessed their pain on a 0 to millimeter mm horizontal VAS. Analgesic medications were recorded throughout the study until disease progression. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. Gastric Cancer. Epub Jul Quality of life in the trastuzumab for gastric cancer trial.

Epub Jun Pharmacokinetic analysis of capecitabine and cisplatin in combination with trastuzumab in Japanese patients with advanced HER2-positive gastric cancer. Cancer Chemother Pharmacol.

Epub Nov Read our disclaimer for details. Results First Posted : November 5, Last Update Posted : November 5, Participants received trastuzumab p Summary of withdrawals represents withdrawals from treatment, rather than withdrawals from study. Baseline Analysis Population Description Full analysis set FAS included all randomized participants who received at least 1 dose of study treatment.

Description OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. Time Frame Baseline BL , Days 1, 8, 15, 22, 43, 64, 85, , , and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis Outcome Measure Data Outcome Measure Data.

Analysis Population Description. Title Overall Survival - Time to Event Description The median time, in months, from the date of randomization to the date Description The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.

Time Frame BL, Days 1, 8, 15, 22, 43, 64, 85, , , and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis Outcome Measure Data Outcome Measure Data.

Statistical Analysis 1. Description PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease PD or date of death, whichever occurs first. Time Frame BL, Days 43, 85, and , and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis Outcome Measure Data Outcome Measure Data.

Description The median time, in months, from the date of randomization to the date of a PFS event. Description TTP was defined as the time from the date of randomization and the date of the first occurrence of PD.

Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.

Title Time to Progression - Time to Event Description The median time, in months, from the date of randomized to the date of Description The median time, in months, from the date of randomized to the date of a TTP event. Title Duration of Response - Percentage of Participants With an Event Description Duration of response was defined for responders as the time from the d Description Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted.

Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma REGARD : an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet ; : 31— Lancet Oncol ; 19 : — Efficacy and safety of pembrolizumab or pembrolizumab plus chemotherapy vs chemotherapy alone for patients with first-line, advanced gastric cancer: the KEYNOTE phase 3 randomized clinical trial.

JAMA Oncol ; 6 : — Ann Oncol ; 31 , S Ann Oncol ; 31 Suppl. Gastric Cancer ; 18 : — Gravalos C, Jimeno A. HER2 in gastric cancer: a new prognostic factor and a novel therapeutic target. Ann Oncol ; 19 : — World J Gastroenterol ; 17 : — HER-2 expression in immunohistochemistry has no prognostic significance in gastric cancer patients.

ScientificWorldJournal ; : Human epidermal growth factor receptor-2 gene amplification in gastric cancer using tissue microarray technology. World J Gastroenterol ; 18 : — Lancet Oncol ; 18 : — J Clin Oncol ; 32 : — J Clin Oncol ; 34 : — Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer JACOB : final analysis of a double-blind, randomised, placebo-controlled phase 3 study.

Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer. N Engl J Med ; : — Gastric Cancer ; 22 : — HER2 expression in gastric cancer: rare, heterogeneous and of no prognostic value - conclusions from cases of two independent series.

Cell Oncol ; 32 : 57— World J Gastroenterol ; 22 : — Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathology ; 52 : — Genetic predictors of response to systemic therapy in esophagogastric cancer.

Cancer Discov ; 8 : 49— Ann Oncol ; 29 : — Clin Cancer Res ; 22 : — Bystander killing effect of DSa, a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity. The impact of implementation of alternative testing strategies remained unclear. Abstract This paper presents a summary of the evidence review group ERG report into trastuzumab for the treatment of human epidermal growth factor receptor 2 HER2 -positive metastatic adenocarcinoma of the stomach mGC or gastro-oesophageal junction.

Publication types Research Support, Non-U.



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