Trial Outcomes & Findings for Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer (NCT NCT02273752)
NCT ID: NCT02273752
Last Updated: 2017-02-03
Results Overview
Stomatitis graded rates and severity will be evaluated and recorded per World Health Organization and Common Terminology Criteria for Adverse Events criteria in the study population.
TERMINATED
PHASE2
2 participants
Day 29
2017-02-03
Participant Flow
Patient were recruited at Winship Cancer Institute of Emory University from November 2014 to December 2015.
Participant milestones
| Measure |
Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)
Patients receive everolimus 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.
Everolimus: Given PO
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)
Patients receive everolimus 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.
Everolimus: Given PO
|
|---|---|
|
Overall Study
Trial was terminated early
|
2
|
Baseline Characteristics
Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer
Baseline characteristics by cohort
| Measure |
Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)
n=2 Participants
Patients receive everolimus 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 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.
Everolimus: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Gender
Female
|
1 Participants
n=5 Participants
|
|
Gender
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.
Stomatitis graded rates and severity will be evaluated and recorded per World Health Organization and Common Terminology Criteria for Adverse Events criteria in the study population.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.
PFS will be evaluated based on rates of cancer progression and time to progression in the population. Progression will be determined using standard RECIST criteria. The median PFS for this study will be estimated by Kaplan-Meier method along with 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 15 of course 1Population: Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.
Pharmacodynamics will be evaluated for phosphorylated and non-phosphorylated ribosomal protein S6 kinase, protein kinase B, and eukaryotic translation initiation factor 4E-binding protein 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.
Percentage of days on therapy will be calculated using the formula: (expected - actual days)/expected x 100.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.
Dose interruptions and adjustments will be made on a per subject basis and total for the population.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.
Frequency of treatments for stomatitis will be collection of prescription and non-prescription interventions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.
Type of treatments for stomatitis will be collection of prescription and non-prescription interventions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.
Response rate will be measured at different time points, e.g. 8, 16, and 24 weeks, and will be summarized as percentage of stable disease, complete remission or partial remission along with 95% confidence interval.
Outcome measures
Outcome data not reported
Adverse Events
Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)
n=2 participants at risk
Patients receive everolimus 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 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.
Everolimus: Given PO
|
|---|---|
|
Metabolism and nutrition disorders
Elevated glucose
|
100.0%
2/2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
1/2
|
|
General disorders
Fatigue
|
50.0%
1/2
|
|
Gastrointestinal disorders
Mucositis
|
50.0%
1/2
|
|
Skin and subcutaneous tissue disorders
Generalized acne
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
50.0%
1/2
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place