Clinical trialPhase 2Terminated
Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer
Phase II Evaluation of Real-Time, Pharmacokinetically Guided Everolimus in Patients With Hormone Receptor Positive Breast Cancer, Pancreatic Neuroendocrine Tumors (PNET), and Renal Cell Carcinoma
- Outcome
- Stopped earlySlow accrual (Enrollment)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- November 2014
- Expected end
- December 2015
- Enrollment
- 2 participants
- Sites
- 2
- Primary outcomes
- Incidence of Stomatitis
- Sponsor
- Other
- Results posted
- 2017-02-03
- Last update
- 3 February 2017
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVE: To determine frequency of any grade of stomatitis at day 29 (cycle 2, day 1) in patients receiving dose-adjusted everolimus. SECONDARY OBJECTIVES: 1. Progression-free survival rates at 6 months. 2. Pharmacodynamic (PD)-inhibition of downstream mammalian target of rapamycin (mTOR) effectors in peripheral blood. 3. Number of dose adjustments required. 4. Percentage of days on therapy. 5. Average minimum concentration (Cmin) values. 6. Frequency and type of treatments for stomatitis. 7. Genetic predictors of stomatitis development in selected outlier patients. OUTLINE: Patients receive everolimus orally (PO) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic therapeutic drug monitoring (TDM) on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6. After completion of study treatment, patients are followed up every 12 weeks.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Incidence of Stomatitis [Day 29].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [6 months].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Downstream Markers of Mammalian Target of Rapamycin (mTOR) Function Measured in Peripheral Blood Mononuclear Cells [Up to day 15 of course 1].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Days on Therapy [Up to 6 months].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Dose Interruptions and Adjustments [Up to 6 months].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Frequency of Treatments for Stomatitis [Up to 6 months].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Type of Treatments for Stomatitis [Up to 6 months].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Rate Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [Up to 24 weeks].