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Bioequivalence Study of IG-001 Versus Nab-paclitaxel in Metastatic or Locally Recurrent Breast Cancer

NCT02064829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2016-03-25

No results posted yet for this study

Summary

The purpose of this study is to demonstrate bioequivalence of IG-001 versus nab-paclitaxel in female patients with metastatic or locally recurrent breast cancer. In addition, the study will compare the safety and tolerance of IG-001 and nab-paclitaxel during the bioequivalence 2-period crossover portion of the study. The study will also evaluate the long-term safety of IG-001 over repeated cycles, up to 4 additional cycles of administration.

Conditions

Interventions

DRUG

Nab-paclitaxel

260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks

DRUG

IG-001

260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks

Sponsors & Collaborators

  • Sorrento Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-02-28
Completion
2015-07-31

Countries

  • United States
  • Georgia
  • Moldova
  • Romania
  • Serbia
  • Singapore
  • Ukraine

Study Locations

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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 NCT02064829 on ClinicalTrials.gov