Status:
COMPLETED
A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects With Solid Tumors
Lead Sponsor:
OncoMed Pharmaceuticals, Inc.
Conditions:
Solid Tumors
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
A phase 1 open-label dose escalation study of OMP-21M18 in subjects with previously treated solid tumour for which there is no remaining standard curative therapy and no therapy with a demonstrated su...
Detailed Description
This is an open-label Phase 1 dose escalation study of OMP-21M18 in subjects with previously treated solid tumors for which there is no remaining standard curative therapy and no therapy with a demons...
Eligibility Criteria
Inclusion
- Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. In addition, subjects must have a tumor that is at least 2 x 2 cm and is radiographically apparent on CT or MRI.
- Subjects must have received their last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C.
- Age \>21 years
- ECOG performance status \<2
- Life expectancy of more than 3 months
- Subjects must have normal organ and marrow function as defined below:
- Leukocytes \>3000/mL
- Absolute neutrophil count \>1000/mL
- Hemoglobin \>9.0 g/dL
- Platelets \>100,000/mL
- Total bilirubin \<1.5 X institutional upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) \<2.5 X institutional ULN
- PT and PTT within institutional ULN
- Creatinine \<1.5 X institutional ULN OR
- Creatinine clearance \>60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
- Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug.
Exclusion
- Subjects receiving any other investigational agents
- Subjects with known brain metastases, uncontrolled seizure disorder, or active neurologic disease
- History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
- Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women or nursing women
- Subjects with known HIV infection
- Known bleeding disorder or coagulopathy
- Subjects receiving heparin, warfarin, or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
- Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00744562
Start Date
August 1 2008
End Date
January 1 2012
Last Update
September 10 2020
Active Locations (3)
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1
California Cancer Care
Greenbrae, California, United States, 94904
2
Stanford University
Stanford, California, United States, 94305
3
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109