Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02391194|
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: AVB-620||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure.
- Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values [ Time Frame: 30 days ]The incidence, nature and severity of adverse events and abnormal laboratory values will be collected and analyzed in the evaluation of the safety of AVB-620.
- Characterize the pharmacokinetic profile of AVB-620 [ Time Frame: 8 days ]The pharmacokinetics (PK) of AVB-620 will be characterized by collecting and reviewing individual subject plasma concentrations and primary parameters, including clearance, Cmax, Cmin, and distribution.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391194
|United States, California|
|Moores UC San Diego Cancer Center|
|La Jolla, California, United States, 92093|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Stanford Hospitals and Clinics|
|Stanford, California, United States, 94305|