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A Phase 1 Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors


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

Thank you

Trial Information

A Phase 1 Dose Escalation Study of OMP-59R5 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 normal organ and marrow function as defined below:

- 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) < 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 (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. 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 immediately.

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 II, III, or IV

10. Subjects with a blood pressure of >140/90 mmHg. The blood pressure must be taken
three times 10 minutes apart. Subjects taking antihypertensive medications must be
taking ≤ 2 medications to obtain this level of blood pressure control.

11. Subjects with EKG evidence of ischemia or ≥ Grade 2 ventricular arrhythmia, subjects
who have a history of acute myocardial infarction within 6 months, or subjects with
unstable angina.

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

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

14. Subjects with >1 grade 1 diarrhea.

Type of Study:

Interventional

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-59R5 in subjects with previously treated solid tumors

Outcome Description:

The number of patients experiencing Adverse Events will be reported.

Outcome Time Frame:

continuous

Safety Issue:

Yes

Principal Investigator

David C. Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Food and Drug Administration

Study ID:

59R5-001

NCT ID:

NCT01277146

Start Date:

December 2010

Completion Date:

August 2013

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
South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229