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Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer

NCT02273752 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-02-03

Study results available
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Summary

This phase II trial studies how well real-time pharmacokinetic therapeutic drug monitoring works in preventing stomatitis from developing in patients with hormone receptor positive breast cancer, pancreatic neuroendocrine tumors, or kidney cancer that are receiving a type of cancer drug called everolimus. Stomatitis is a common side effect of everolimus that causes inflammation of the mouth, with or without oral ulcers, and frequently leads to patients discontinuing the medication. Monitoring the blood levels of everolimus and making adjustments in a patient's dose may be able to decrease the incidence of stomatitis, while maintaining the effectiveness of everolimus to treat the cancer.

Conditions

  • Estrogen Receptor-positive Breast Cancer
  • Gastrinoma
  • Glucagonoma
  • HER2-negative Breast Cancer
  • Insulinoma
  • Mucositis
  • Oral Complications
  • Pancreatic Polypeptide Tumor
  • Progesterone Receptor-positive Breast Cancer
  • Recurrent Breast Cancer
  • Recurrent Islet Cell Carcinoma
  • Recurrent Renal Cell Cancer
  • Somatostatinoma
  • Stage III Renal Cell Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Stage IV Renal Cell Cancer

Interventions

DRUG

Everolimus

Given PO

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • R. Donald Harvey, PharmD · Emory University/Winship Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02273752 on ClinicalTrials.gov