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A Phase 1 Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors

Phase 1
18 Years
90 Years
Open (Enrolling)
Solid Tumors

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Trial Information

A Phase 1 Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors

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 1 cm in a single dimension 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 >18 years

4. ECOG performance status <2 (see Appendix B)

5. Life expectancy of more than 3 months

6. Subjects must have adequate organ and marrow function as defined below:

Absolute neutrophil count >1000/µL Hemoglobin >9.0 g/dL Platelets >100,000/µL Total
bilirubin <1.5 X institutional upper limit of normal (ULN) AST (SGOT) and ALT (SGPT)
< 3 X institutional ULN (for subjects with hepatic metastases < 5 X institutional
ULN) PT and PTT within 1.5 X 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 (barrier method of birth control, abstinence) prior to study entry and
from study entry through at least 6 months after discontinuation of study drug.
Should a woman enrolled in the study or a female partner of a man enrolled in the
study become pregnant or suspect she is pregnant while participating in this study or
within 6 months after discontinuation of study, she should inform the Investigator

8. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Subjects receiving any other investigational agents

2. Subjects with brain metastases (subjects must have a CT scan or MRI of the head
within 28 days prior to enrollment to rule out 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, except for
subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may
be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.

9. New York Heart Association Classification III, or IV (see Appendix D)

10. Subjects with known clinically significant gastrointestinal disease including, but
not limited to, inflammatory bowel disease.

11. Subjects with known osteopenia or osteoporosis.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety of OMP-18R5 in subjects with previously treated solid tumors

Outcome Time Frame:

Subjects will be assessed for dose limiting toxicity from Days 0-28. Adverse events will be reported through 30 days after the last dose.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

June 2014

Related Keywords:

  • Solid Tumors
  • Phase 1
  • dose escalation
  • histologically confirmed
  • malignancy metastatic
  • Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
South Texas Accelerated Research Therapeutics San Antonio, Texas  78229
UCLA Santa Monica Hematology-Oncology Santa Monica, California  90404