NCT02064829

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

An Open-label, Randomized, Multi-center, Single-Dose, 2-Sequence, 2-Period, Crossover, Comparative Bioequivalence Study of IG-001 (Cb-paclitaxel) 260 mg/m2 Versus Nab-paclitaxel 260 mg/m2 Administered Intravenously With an Open-Label Extension of IG-001 in Patients With Metastatic or Locally Recurrent Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to compare the pharmacokinetics (PK) of IG-001 and nab-paclitaxel in patients with metastatic or locally recurrent breast cancer. Patients meeting the eligibility criteria will be randomized to determine which drug is administered first. * Patients randomized to Group 1 will receive a single dose of IG-001 (Period 1) followed 3 weeks later by a single dose of nab-paclitaxel (Period 2). * Patients randomized to Group 2 will receive a single dose of nab-paclitaxel (Period 1) followed 3 weeks later by a single dose of IG-001 (Period 2). Blood samples for PK analysis will be taken at specified times before, during, and after the infusion of each drug in Periods 1 and 2. Following successful completion of Period 1 and Period 2, patients may be eligible for up to 4 additional cycles of treatment with IG-001 in the extension study. Safety will be monitored throughout the study.

Conditions

• Metastatic Breast Cancer
• Locally Recurrent Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-02-01
• Completion: 2015-07-01
• First posted: 2014-02-17
• Last updated: 2016-03-25

Locations

20 sites across 7 countries: United States, Georgia, Moldova, Romania, Serbia, Singapore, Ukraine