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Safety/Biomarker Study of CNTO 95 and Avastin in Solid Tumors

NCT00888043 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-03-11

No results posted yet for this study

Summary

The purpose of this research study is to find out what side effects the combination of the two study drugs, bevacizumab (Avastin) and CNTO 95 have on the body and to determine the highest dose of CNTO 95 that can be given with bevacizumab that is safe and well tolerated.

Conditions

Interventions

DRUG

CNTO 95 and avastin

STAGE 1 (Dose escalation) Cohort # subjects CNTO 95 Bevacizumab * 2 3-6 2.5 mg/kg IV Q3 weeks 7.5 mg/kg IV Q3 weeks * 1 3-6 2.5 mg/kg IV Q3 weeks 15 mg/kg IV Q3 weeks 1. 3-6 5 mg/kg IV Q3weeks 15 mg/kg IV Q3 weeks 2. 3-6 10 mg/kg IV Q3 weeks 15 mg/kg IV Q3 weeks STAGE 2 (Biomarker) Cohort # subjects CNTO 95 Bevacizumab 3. 20 Recommended Phase II Dose Recommended Phase II Dose

Sponsors & Collaborators

  • Centocor, Inc.

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Herbert Hurwitz, MD

    lead OTHER

Principal Investigators

  • Herbert I Hurwitz, MD · Duke University

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00888043 on ClinicalTrials.gov