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

Not Recruiting

Trial ID: NCT00744562


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.

Official Title

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


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


drug: OMP-21M18

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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