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

Trial Source

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Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Solid Cancers
Reference Study ID Number: PCD4989g www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. Only)
See all trial contact details
Primary Contact Details
Recruiting
Recruitment Status
NCT01375842
Primary Trial ID Number

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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.
Research Details
    Sorry, this information is not available
Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Atezolizumab (MPDL3280A), an engineered anti-PDL1

Study Arm Groups : A

Intervention Type
See Interventions above
Primary Outcome Measures
    Incidence of dose limiting toxicities (DLTs); Up to day 21; Nature of dose limiting toxicities (DLTs); Up to day 21
Secondary Outcome Measures
    Incidence of adverse events graded according to NCI CTCAE v4.0; Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first; Nature of adverse events graded according to NCI CTCAE v4.0; Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first; Severity of adverse events graded according to NCI CTCAE v4.0; Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
604
Participant Inclusion Criteria
    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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
EC1A 7BE
Trial Contact(s)
Primary Trial Contact
Reference Study ID Number: PCD4989g www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. Only)
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
France, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
PCD4989g
Sponsor(s)
Genentech, Inc.
Key Dates

Recruitment Start Date

Jun 2011

Recruitment End Date

Sep 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

16 Jun 2011

Date updated in source

14 Jan 2016