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A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects With Solid Tumors


Phase 1
21 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

A Phase 1 Dose Escalation Study of OMP-21M18 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 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the safety of OMP-21M18 in subjects with previously treated solid tumors

Outcome Time Frame:

continuous

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

M18-001

NCT ID:

NCT00744562

Start Date:

August 2008

Completion Date:

January 2012

Related Keywords:

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

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Stanford UniversityStanford, California  94305
California Cancer CareGreenbrae, California  94904