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A Phase 1 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01375842
First received: June 16, 2011
Last updated: January 14, 2016
Last verified: January 2016

June 16, 2011
January 14, 2016
June 2011
September 2017   (final data collection date for primary outcome measure)
  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to day 21 ] [ Designated as safety issue: No ]
  • Nature of dose limiting toxicities (DLTs) [ Time Frame: Up to day 21 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01375842 on ClinicalTrials.gov Archive Site
  • Incidence of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Nature of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Severity of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 1 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase I, Open Label, Dose Escalation Study of the Safety and Pharmacokinetics of MPDL3280A Administered Intravenously As a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies
This Phase I, multicenter, first in human, open-label, dose escalation study will evaluate the safety, tolerability, and pharmacokinetics of Atezolizumab administered as single agent by intravenous (IV) infusion to patients with locally advanced or metastatic solid malignancies or hematologic malignancies.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1
Intravenous (IV) infusion repeating dose
Experimental: A
Intervention: Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
604
April 2019
September 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age >/=18 years, patients who are <18 years old may be enrolled after consultation with the Medical Monitor
  • Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy
  • Representative tumor specimens in paraffin blocks/unstained slides, with an associated pathology report
  • Adequate hematologic and end organ function
  • Measurable disease per RECIST for patients with solid malignancies or per protocol-specified disease-specific criteria for patients with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
  • History or risk of autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, etc.)
  • History of HIV, hepatitis B, or hepatitis C infection
  • Any signs or symptoms of infection
  • Malignancies other than disease under study within 5 years
  • Prior allogeneic stem cell transplant
Both
18 Years and older   (Adult, Senior)
No
Contact: Reference Study ID Number: PCD4989g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   France,   Spain,   United Kingdom
 
NCT01375842
PCD4989g, 2011-001422-23, GO27831
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP