Diagnosis of MelanomaNCT01593579
Autonomic Phenotype Before and After Akt Inhibition
An observational study of Diagnosis of Melanoma, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diagnosis of Melanoma
- What is being tested?
- Autonomic Function Tests and supine and standing catecholamines
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diagnosis of Melanoma
- Being tested
- Autonomic Function Tests, supine and standing catecholamines
- Keywords
- melanoma, autonomic failure, hypotension, akt therapy
- Medical subject headings
- Melanoma, Pure Autonomic Failure, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic Function TestsBehavioural
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.
supine and standing catecholaminesOther
patients will have blood drawn from supine and standing catecholamines.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Autonomic Function Tests; Other: supine and standing catecholamines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop in systolic blood pressure before and after Akt treatment
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2015 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: Planned parent study never enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis of MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satish R. Raj, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593579
- Sponsor's protocol ID
- 120390
- Other IDs
- VR3689
- Status last verified
- Dec 2014
- First submitted
- 4 May 2012
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Phenotype Before and After Akt Inhibition: Akt Therapy for Melanoma Sub-study
- ClinicalTrials.gov ID
- NCT01593579
- Acronym / sponsor ID
- 120390
- Conditions
- Diagnosis of Melanoma
- Keywords
- melanoma, autonomic failure, hypotension, akt therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Planned parent study never enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Melanoma | – | Behavioral: Autonomic Function Tests, Other: supine and standing catecholaminesPatients with Melanoma that are enrolled in a clinical trial at the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autonomic Function TestsPatients 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. | Behavioural | Patients with Melanoma |
| supine and standing catecholaminespatients will have blood drawn from supine and standing catecholamines. | Other | Patients with Melanoma |
Primary outcome
Drop in systolic blood pressure before and after Akt treatment
Time frame: 8 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosis of Melanoma, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drop in systolic blood pressure before and after Akt treatment (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.