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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Solid Cancers	Drug: MPDL3280A	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	344
Study Start Date:	April 2011
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: MPDL3280A Intravenous (IV) infusion repeating dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375842

Contacts

Contact: Please reference Study ID Number: PCD4989g www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

United States, Arizona
	Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
	Recruiting
Los Angeles, California, United States, 90025
	Recruiting
Stanford, California, United States, 94305
United States, Connecticut
	Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
	Recruiting
Tampa, Florida, United States, 33612-9497
United States, Maryland
	Recruiting
Baltimore, Maryland, United States, 21231
United States, Massachusetts
	Recruiting
Boston, Massachusetts, United States, 02215
	Recruiting
Boston, Massachusetts, United States, 02114
United States, Nevada
	Recruiting
Las Vegas, Nevada, United States, 89169
United States, New York
	Recruiting
Albany, New York, United States, 12206
United States, North Carolina
	Recruiting
Huntersville, North Carolina, United States, 28078
United States, Tennessee
	Recruiting
Nashville, Tennessee, United States, 37232
	Recruiting
Nashville, Tennessee, United States, 37203
United States, Virginia
	Recruiting
Chesapeake, Virginia, United States, 23320
France
	Recruiting
Lyon, France, 69008
	Recruiting
Toulouse, France, 31052
	Recruiting
Villejuif, France, 94805
Spain
	Recruiting
Barcelona, Spain, 08035
United Kingdom
	Recruiting
London, United Kingdom, EC1M 6BQ

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Clinical Trials

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT01375842 History of Changes
Other Study ID Numbers:	PCD4989g, GO27831
Study First Received:	June 16, 2011
Last Updated:	April 10, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

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

Additional relevant MeSH terms:

Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013