A study to look at how safe different doses of atezolizumab were for patients – and how this medicine was processed through the body

A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors

  • Cancer
  • Solid Tumors
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • France
  • Spain
  • United Kingdom
  • United States
Trial Identifier:

NCT01375842 2011-001422-23, GO27831 PCD4989g

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT01375842,PCD4989g,2011-001422-23, GO27831 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      Atezolizumab is a new medicine designed to work on the immune system, and this type of medicine is known as an immunotherapy. Patients with different types of cancers received different amounts of the study medicine to find out which dose of atezolizumab was safe, and which dose could be given to patients in future studies.

      Trial Summary

      This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT01375842,PCD4989g,2011-001422-23, GO27831 Trial Identifier
      Atezolizumab Treatments
      Tumors, Hematologic Malignancies Condition
      Official Title

      A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Participants who are 16 to 17 years old would be enrolled after consultation with the Medical Monitor
      • Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard curative therapy exists
      • Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report
      • Adequate hematologic and end organ function
      • Measurable disease per RECIST v1.1 for participants with solid malignancies. Disease-specific criteria for participants with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma
      • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
      • For participants who will undergo serial biopsy in dose-escalation cohort, baseline tumor tissue samples should be of core needle biopsies for deep tumor tissue or organs or excisional or punch biopsies for cutaneous or subcutaneous lesions (>/=5 millimeter [mm] in diameter amenable to serial biopsy)
      Exclusion Criteria
      • Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
      • Known hypersensitivity to pharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
      • History or risk of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis)
      • History of human immunodeficiency virus (HIV) infection, active hepatitis B (chronic or acute), or hepatitis C infection
      • Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
      • Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1
      • Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation

      For the latest version of this information please go to www.forpatients.roche.com

       

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