Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of the Safety and Pharmacokinetics of MEHD7945A in Patients With Locally Advanced or Metastatic Epithelial Tumors

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: September 20, 2010
Last updated: February 4, 2015
Last verified: February 2015

This is a Phase I, multicenter, open-label study of MEHD7945A in patients with incurable, locally advanced, or metastatic epithelial malignancies that have progressed despite standard therapy or for which no standard therapy exists.

Condition Intervention Phase
Epithelial Tumors, Malignant
Drug: MEHD7945A
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 MEHD7945A Administered Intravenously to Patients With Locally Advanced or Metastatic Epithelial Tumors

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1-28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic measures (total exposure, maximum and minimum serum concentration, clearance, and steady state) [ Time Frame: Days 1-28 ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: November 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: MEHD7945A
Intravenous escalating dose


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

Inclusion Criteria:

  • Life expectancy >/= 12 weeks
  • Availability and willingness to provide sufficient tumor tissue sample for testing
  • Dose-escalation stage: Patients with histologically documented incurable, locally advanced, or metastatic epithelial malignancy that has progressed despite standard therapy or for which no standard therapy exists
  • Expansion stage: Patients with one of the following epithelial, histologically-documented, incurable, locally advanced, or metastatic tumor that has progressed despite standard therapy or for which no standard therapy exists: colorectal cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, or pancreatic cancer
  • Use of an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for men and women of childbearing potential while enrolled in the study

Exclusion Criteria:

  • < 4 weeks since the last anti-tumor therapy prior to Day 1 of study treatment
  • Major surgical procedure within 4 weeks prior to Day 1 of study treatment
  • Leptomeningeal disease as the only manifestation of the current malignancy
  • Active infection requiring IV antibiotics
  • Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
  • Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
  • Current severe, uncontrolled systemic disease
  • History of cardiac heart failure of any New York Heart Association criteria or serious cardiac arrhythmia requiring treatment
  • History of myocardial infarction within 6 months before Day 1, or history of unstable angina
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • History of interstitial lung disease
  • History of severe allergic or hypersensitivity reaction to other therapeutic antibodies that required discontinuation of therapy
  • Known human immunodeficiency virus (HIV) infection
  • Primary central nervous system (CNS) malignancy or untreated/active CNS metastases
  • Significant traumatic injury within 4 weeks prior to Day 1 of study treatment
  • Pregnancy or lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01207323

United States, Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Texas
Houston, Texas, United States, 77030
Barcelona, Spain, 08035
Madrid, Spain, 28050
Valencia, Spain, 46010
Sponsors and Collaborators
Genentech, Inc.
Study Director: Andrea Pirzkall, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc. Identifier: NCT01207323     History of Changes
Other Study ID Numbers: DAF4873g, GO00765
Study First Received: September 20, 2010
Last Updated: February 4, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type processed this record on March 03, 2015