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

NCT00744562 | Completed Phase 1

• 1 other identifier: M18-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Solid Tumors

Keywords

Phase 1,; dose escalation,; histologically; confirmed; malignancy; metastatic

Outcome Measures

Primary Outcomes (1)

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

  continuous

Secondary Outcomes (1)

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

  First 8 doses and following treatment termination

Study Arms (1)

Open-label OMP-21M18

EXPERIMENTAL

Drug: OMP-21M18

Interventions

OMP-21M18 DRUG

0.5, 1, 2.5, 5, and 10 mg/kg weekly until day 56. If patient has not progressed may continue with original dose administered every other week until progression

Open-label OMP-21M18

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Age \>21 years
• ECOG performance status \<2
• Life expectancy of more than 3 months
• 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

You may not qualify if:

• Subjects receiving any other investigational agents
• Subjects with known brain metastases, uncontrolled seizure disorder, or active neurologic disease
• History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
• 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
• Pregnant women or nursing women
• Subjects with known HIV infection
• Known bleeding disorder or coagulopathy
• Subjects receiving heparin, warfarin, or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
• Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (3)

California Cancer Care

Greenbrae, California, 94904, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

demcizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

US (3)