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