NCT02391194

Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery

A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Avelas Biosciences, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.

Detailed description

This study will examine the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study will also characterize the pharmacokinetics of AVB-620 in this subject population and determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	AVB-620

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-03-18
• Last updated: 2017-03-22

Locations

3 sites across 1 country: United States