A Study to Assess the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Administered Intravenously (IV) as a Single Agent or in Combination With Chemotherapy in Chinese Participants With Locally Advanced or Metastatic Solid Tumors

Sponsor
Hoffmann-La Roche
Study ID
NCT02825940
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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.
  • Gemcitabine — DRUG
    Gemcitabine will be administered to participants with NSCLC at a dose of 1250 mg/m\^2 on Days 1 and 8.
  • Cisplatin — DRUG
    Cisplatin will be administered to participants with NSCLC at a dose of 75 mg/m\^2 on Day 1.

Study Details

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.

Key Dates

Start date
Aug 4, 2016
Status verified
Jan 2023
Primary completion
Jan 14, 2020
Completion
Nov 4, 2022

Study Design

Enrollment
120 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab Monotherapy: PK and Extension Phases
    Participants during the PK and extension phases of the study will receive atezolizumab alone at a dose of 1200 milligrams (mg) IV every 3 weeks (q3w) (in 21-day cycles) continuously until loss of clinical benefit, disease progression, unacceptable toxicity, participant or physician decision to discontinue, or death. Study treatment may continue beyond disease progression based on the investigator's discretion.
  • Experimental: Atezolizumab and Chemotherapy: Extension Phase
    Participants during the extension phase of the study will receive atezolizumab at a dose of 1200 mg IV on Day 1 in combination with gemcitabine at a dose of 1250 milligrams per square meter (mg/m\^2) on Days 1 and 8 and cisplatin at a dose of 75 mg/m\^2 on Day 1 (four or six 21-day cycles at the discretion of the investigator), followed by atezolizumab as a single agent at a dose of 1200 mg IV q3w on Day 1 of a 21-day cycle) as maintenance treatment continuously until loss of clinical benefit, disease progression, unacceptable toxicity, participant or physician decision to discontinue, or death. Study treatment may continue beyond disease progression based on the investigator's discretion.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Atezolizumab [ 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) ]

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