Status:
COMPLETED
A Study of the Safety and Pharmacokinetics (PK) of MEHD7945A in Participants With Locally Advanced or Metastatic Epithelial Tumors
Lead Sponsor:
Genentech, Inc.
Conditions:
Epithelial Tumors, Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, multicenter, open-label study of MEHD7945A in participants with incurable, locally advanced, or metastatic epithelial malignancies that have progressed despite standard therapy or f...
Eligibility Criteria
Inclusion
- Life expectancy greater than or equal to (\>/=) 12 weeks
- Availability and willingness to provide sufficient tumor tissue sample for testing
- Dose-escalation stage: Participants 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: Participants 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: CRC, NSCLC, HNSCC, 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
- Less than (\<) 4 weeks since the last anti-tumor therapy prior to Day 1 of study treatment
- Major surgical procedure within 4 weeks prior to Cycle 1, Day 1
- 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 Cycle 1, 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 before Cycle 1, Day 1
- Pregnancy or lactation
Key Trial Info
Start Date :
November 9 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2018
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01207323
Start Date
November 9 2010
End Date
April 23 2018
Last Update
May 1 2018
Active Locations (6)
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1
Uni of Colorado Cancer Center; Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
2
Massachusetts General Hospital.
Boston, Massachusetts, United States, 02114
3
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
4
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035