Pilot Study of Antineoplastic

Overview

About this study

The purpose of this study is to use therapeutic drug monitoring (trough plasma concentrations of dabrafenib, hydroxy dabrafenib, and/or trametinib) along with CYP3A4/CYP3A5 and CYP2C8 genotyping and BRAF mutation quantification will correlate with effectiveness (based on imaging studies) and/or toxicity (pyrexia, liver dysfunction, rash) in known melanoma patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients ≥ 18 years of age.
  • Metastatic melanoma harbors a BRAF mutation (V600 E or K).
  • No known central nervous system metastasis.
  • Currently not receiving steroids greater than physiologic dosing for patients with known adrenal insufficiency.
  • Patients currently undergoing standard of care therapy with full dose dabrafenib and trametinib.
  • Willingness to undergo study procedures/blood collection as outline in the protocol.

Exclusion Criteria: 

  • Anyone not meeting the inclusion criteria.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/11/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lisa Kottschade, APRN, C.N.P.

Open for enrollment

Contact information:

Leah Nelson

(507) 538-0145

Nelson.Leah@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20589708

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