Autonomic Phenotype Before and After Akt Inhibition

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01593579
First received: May 4, 2012
Last updated: January 7, 2013
Last verified: January 2013

May 4, 2012
January 7, 2013
May 2012
May 2015   (final data collection date for primary outcome measure)
Drop in systolic blood pressure before and after Akt treatment [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01593579 on ClinicalTrials.gov Archive Site
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Autonomic Phenotype Before and After Akt Inhibition
Autonomic Phenotype Before and After Akt Inhibition: Akt Therapy for Melanoma Sub-study

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.

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Observational
Time Perspective: Prospective
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Probability Sample

Patients will have a diagnosis of Melanoma and be participating in a clinical trial with an arm using oral Akt therapy. Patients will be recruited from the Vanderbilt Ingram Cancer Center.

Diagnosis of Melanoma
  • 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.
Patients with Melanoma
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
Interventions:
  • Behavioral: Autonomic Function Tests
  • Other: supine and standing catecholamines
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
May 2016
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Satish Raj, MD, MSCI 615-322-2931 adcresearch@vanderbilt.edu
Contact: Jeffrey Sosman, MD 615-343-6653 jeff.sosman@Vanderbilt.Edu
United States
 
NCT01593579
120390, VR3689
No
Satish R. Raj, Vanderbilt University
Vanderbilt University
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Not Provided
Vanderbilt University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP