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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Cancers

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose limiting toxicities (DLTs)

Outcome Time Frame:

Up to day 21

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

PCD4989g

NCT ID:

NCT01375842

Start Date:

April 2011

Completion Date:

April 2017

Related Keywords:

  • Solid Cancers
  • PD-L1
  • PD-1
  • lymphoma
  • esophageal cancer
  • antiPD-L1
  • MPDL3280A
  • Solid tumor
  • Renal cell Carcinoma (RCC)
  • Melanoma (MEL)
  • Non-small Cell Lung Cancer (NSCLC)
  • Breast Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Colorectal Cancer
  • Heme Malignancies
  • Non-Hodgkin Lymphoma
  • Multiple Myeloma
  • MPDL320A
  • Neoplasms
  • Hematologic Neoplasms

Name

Location
New Britain, Connecticut  06052
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Nashville, Tennessee  37203-1632
McLean, Virginia  22101
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Las Vegas, Nevada  89109