A Phase 1 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors | Recruiting
A Phase 1 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors

Trial Source

There is no location for this trial

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

Health 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
Summary
This Phase I, multicenter, first in human, open-label, dose escalation study will evaluate the safety, tolerability, and pharmacokinetics of MPDL3280A 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
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : MPDL3280A

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
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
344
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - 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
  • disease-specific criteria for patients with hematologic malignancies
  • - ECOG: 0-1
  • Exclusion Criteria:
  • - Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
  • - History or risk of autoimmune disease (i.e. SLE, RA, inflammatory bowel disease, Type
  • I DM, 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
Trial Location(s)
GSK Investigational Site
London
EC1M 6BQ
Trial Contact(s)
Primary Trial Contact
Reference Study ID Number: PCD4989g www.roche.com/about_roche/roche_worldwide.htm
global.rochegenentechtrials@roche.com
888-662-6728 (U.S. Only)
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, France, Spain, United Kingdom
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

Apr 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

16 Jun 2011

Last Updated

07 Apr 2014