Autonomic Phenotype Before and After Akt Inhibition

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. Identifier: NCT01593579
Recruitment Status : Withdrawn (Planned parent study never enrolled)
First Posted : May 8, 2012
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):
Satish R. Raj, 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.

Condition or disease Intervention/treatment
Diagnosis of Melanoma Behavioral: Autonomic Function Tests Other: supine and standing catecholamines

Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Prospective
Official Title: Autonomic Phenotype Before and After Akt Inhibition: Akt Therapy for Melanoma Sub-study
Study Start Date : May 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Group/Cohort Intervention/treatment
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
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.

Primary Outcome Measures :
  1. Drop in systolic blood pressure before and after Akt treatment [ Time Frame: 8 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01593579

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University

Responsible Party: Satish R. Raj, Assistant Professor, Vanderbilt University Identifier: NCT01593579     History of Changes
Other Study ID Numbers: 120390
VR3689 ( Other Identifier: Vanderbilt )
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by Satish R. Raj, Vanderbilt University:
autonomic failure
akt therapy

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas