Autonomic Phenotype Before and After Akt Inhibition

Diagnosis of Melanoma Clinical Trial

Official title:

Autonomic Phenotype Before and After Akt Inhibition: Akt Therapy for Melanoma Sub-study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01593579
• Other study ID #: 120390
• Secondary ID: VR3689
• Status: Withdrawn
• Phase: N/A
• First received: May 4, 2012
• Last updated: December 18, 2014
• Start date: May 2012
• Est. completion date: May 2016

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diagnosis of Melanoma
• Melanoma

Intervention

Behavioral:
• Autonomic Function Tests
Patients will undergo Autonomic Function testing (AFT) before and 8 hours after Akt Inhibition therapy. AFT includes: Supine & standing heart rate & blood pressure, 10 minute head up tilt, cardiac output, sinus arrhythmia, hyperventilation, sustained handgrip, valsalva manuever, and cold pressor test.

Other:
• supine and standing catecholamines
patients will have blood drawn from supine and standing catecholamines.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drop in systolic blood pressure before and after Akt treatment		8 hours	No