Autonomic Phenotype Before and After Akt Inhibition

Withdrawn

• Conditions: Diagnosis of Melanoma
• Interventions: Behavioral: Autonomic Function Tests; Other: supine and standing catecholamines

• Registration Number: NCT01593579
• Lead Sponsor: Vanderbilt University

Brief Summary

Some Akt inhibitors have produced functional cardiovascular effects such as marked hypotension that may limit their clinical benefit. There are no current data on whether this autonomic failure presents in humans at clinically used doses. We will test the hypothesis that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-23
• Primary Completion: 2015-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosed with melanoma with a BRAF mutation and relapse following therapy with a BRAF inhibitor
• Enrolled in a clinical trial through the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor
• Able and willing to provide informed consent

Exclusion Criteria

• Factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
• Unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Melanoma	supine and standing catecholamines	Patients with Melanoma that are enrolled in a clinical trial at the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor
Patients with Melanoma	Autonomic Function Tests	Patients with Melanoma that are enrolled in a clinical trial at the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor

Primary Outcome Measures

Name	Time	Method
Drop in systolic blood pressure before and after Akt treatment	8 hours

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States