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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01068977
Other study ID # OAM4224g
Secondary ID
Status Completed
Phase Phase 1
First received February 12, 2010
Last updated May 18, 2017
Start date August 2007
Est. completion date January 2010

Study information

Verified date May 2017
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous (IV) infusion in patients with advanced solid malignancies that are refractory to or for which there is no standard of care. The study consists of a dose-escalation stage, an expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation stage testing the combination of MetMAb, at two different doses with bevacizumab at a recommended dose.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy

- Disease that is measurable or evaluable by Response Evaluation Criteria In Solid Tumors (RECIST)

- Life expectancy =12 weeks

Exclusion Criteria:

- Less than 4 weeks since the last anti-tumor therapy

- Patients receiving erythropoietin products

- Active infection requiring antibiotics

- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs

- Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy

- Clinically important history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis

- Known human immunodeficiency virus infection

- Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
bevacizumab
Repeating intravenous dose
MetMAb
Repeating escalating intravenous dose
MetMAb
Repeating intravenous dose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of MetMAb alone or in combination with bevacizumab will be assessed (frequency and nature of dose-limiting toxicities; nature, severity, and relatedness of adverse events; changes in vital signs and clinical laboratory parameters) Length of study
Secondary Objective response, defined as a complete or partial response confirmed =4 weeks after initial documentation Length of study
Secondary Duration of objective response Length of study
Secondary Progression-free survival Length of study
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