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Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects

NCT01516307 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2020-09-16

No results posted yet for this study

Summary

The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.

Conditions

Interventions

BIOLOGICAL

OPT-822/OPT-821(30 μg/100 μg)

Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. OPT-822 and OPT-821 are combined at time of injection.

BIOLOGICAL

Phosphate Buffer Saline (PBS)

Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.

DRUG

Cyclophosphamide

Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.

Sponsors & Collaborators

  • OBI Pharma, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-08-31
Completion
2019-08-31
FDA Drug
Yes

Countries

  • United States
  • China
  • India
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT01516307 on ClinicalTrials.gov