Clinical trial · Observational
Autonomic Phenotype Before and After Akt Inhibition
Autonomic Phenotype Before and After Akt Inhibition: Akt Therapy for Melanoma Sub-study
NCT01593579CI-TRIAL-00016411withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Planned parent study never enrolled
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diagnosis of Melanoma | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autonomic Function Tests | Behavioral | — | UNRESOLVED |
| supine and standing catecholamines | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with Melanoma
- description
- 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
- interventionNames
- Behavioral: Autonomic Function Tests
- Other: supine and standing catecholamines
Primary outcomes (1)
- measure
- Drop in systolic blood pressure before and after Akt treatment
- timeFrame
- 8 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.