Atezolizumab
DrugAtezolizumab will be administered at a dose of 1200 mg IV q3w (in 21-day cycles), except for participants with NSCLC who will be administered atezolizumab at a dose of 1200 mg IV on Day 1.
Other names: MPDL3280A, RO5541267
NCT Number: NCT02825940
This Phase I, open-label, multicenter study will evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of atezolizumab as monotherapy in Chinese participants with locally advanced or metastatic gastric cancer, nasopharyngeal cancer, esophageal cancer, and hepatocellular carcinoma (HCC) that are refractory to standard therapeutic modalities and for whom no further standard therapy is available or who have refused standard therapy; and the safety and preliminary anti-tumor activity of atezolizumab in combination with gemcitabine and cisplatin in Chinese participants with Stage IV, treatment-naive non-small cell lung cancer (NSCLC). The study will consist of a pharmacokinetic (PK) phase and an extension phase.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Beijing Cancer Hospital, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atezolizumab will be administered at a dose of 1200 mg IV q3w (in 21-day cycles), except for participants with NSCLC who will be administered atezolizumab at a dose of 1200 mg IV on Day 1.
Other names: MPDL3280A, RO5541267
Gemcitabine will be administered to participants with NSCLC at a dose of 1250 mg/m^2 on Days 1 and 8.
Cisplatin will be administered to participants with NSCLC at a dose of 75 mg/m^2 on Day 1.
Time frame: Pre-dose (0 hours [h]), 0.5h post-dose (PtD) at Day (D) 1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Time frame: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Time frame: Pre-dose (0h), 0.5h PtD at D 1; D2, 4, 8, 15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Time frame: Pre-dose (0h), 0.5h PtD at D 1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Time frame: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Time frame: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Time frame: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Time frame: From the first occurrence of a PR or CR through the end of study (maximum up to 3 years)
Time frame: From the first occurrence of a documented OR to the first occurrence of disease progression, whichever occurs first (maximum up to 3 years)
Time frame: From the first dose of atezolizumab (Day 1) to the first occurrence of disease progression (maximum up to 3 years)
Time frame: From the first dose of atezolizumab (Day 1) to the first occurrence of disease progression or death, whichever comes first (maximum up to 3 years)
Time frame: From the first dose of atezolizumab (Day 1) to death from any cause (maximum up to 3 years)
Time frame: 6 Months; 1 Year
Time frame: From baseline through the end of study (maximum up to 3 years)
Time frame: From first dose of atezolizumab (Day 1) through the end of study (maximum up to 3 years)
Hoffmann-La Roche
Industry
A Phase I, Open-Label Study to Assess the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Administered Intravenously as a Single Agent or in Combination With Chemotherapy in Chinese Patients With Locally Advanced or Metastatic Solid Tumors
Acronym: IMYO29233
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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