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.
Stanford Investigator(s):
Intervention(s):
- drug: OMP-21M18
Eligibility
Inclusion Criteria:
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
institutional normal
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.
Exclusion Criteria:
1. Subjects receiving any other investigational agents
2. Subjects with known brain metastases, uncontrolled seizure disorder, or active
neurologic disease
3. History of a significant allergic reaction attributed to humanized or human monoclonal
antibody therapy
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
study requirements
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
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.