Trial Search Results
A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects With Solid Tumors
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 survival benefit.
Stanford is currently not accepting patients for this trial.
OncoMed Pharmaceuticals, Inc.
- Drug: OMP-21M18
1. 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.
2. 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.
3. Age >21 years
4. ECOG performance status <2
5. Life expectancy of more than 3 months
6. 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
7. 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.
1. Subjects receiving any other investigational agents
2. Subjects with known brain metastases, uncontrolled seizure disorder, or active
3. History of a significant allergic reaction attributed to humanized or human monoclonal
4. 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
5. Pregnant women or nursing women
6. Subjects with known HIV infection
7. Known bleeding disorder or coagulopathy
8. Subjects receiving heparin, warfarin, or other similar anticoagulants. Note: Subjects
may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
9. Subjects with known clinically significant gastrointestinal disease including, but not
limited to, inflammatory bowel disease
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study