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.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01207323
First received: September 20, 2010
Last updated: October 30, 2012
Last verified: October 2012
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Purpose
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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
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: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: MEHD7945A
Intravenous escalating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207323
Locations
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| Spain | |
| Madrid, Spain, 28050 | |
| Valencia, Spain, 46010 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Andrea Pirzkall, M.D. | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01207323 History of Changes |
| Other Study ID Numbers: | DAF4873g, GO00765 |
| Study First Received: | September 20, 2010 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013