Trial Outcomes & Findings for Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously Treated With Surgery (NCT NCT02031536)
NCT ID: NCT02031536
Last Updated: 2023-06-29
Results Overview
DFS is defined as time from randomization to disease recurrence or death, whichever occurred first. Patients who are still alive are censored at the last date of known free of recurrence.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
assessed every 12 weeks while on treatment and then every 3 months if < 2 years from study entry; every 6 months up to 5 years from study entry or recurrence, whichever occurred first
Results posted on
2023-06-29
Participant Flow
This study was activated on January 17, 2014, accrued its first patient on April 10, 2014, and closed to accrual on March 30, 2015. Two patients, both from Stanford University, were randomized to the trial.
Participant milestones
| Measure |
Arm A (Everolimus)
Patients receive everolimus PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
everolimus: Given PO
|
Arm B (Placebo)
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Everolimus)
Patients receive everolimus PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
everolimus: Given PO
|
Arm B (Placebo)
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
|
|---|---|---|
|
Overall Study
ineligible
|
1
|
0
|
Baseline Characteristics
Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously Treated With Surgery
Baseline characteristics by cohort
| Measure |
Arm A (Everolimus)
n=2 Participants
Patients receive everolimus PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
everolimus: Given PO
|
Arm B (Placebo)
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age between 45-49
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: assessed every 12 weeks while on treatment and then every 3 months if < 2 years from study entry; every 6 months up to 5 years from study entry or recurrence, whichever occurred firstPopulation: All enrolled patients
DFS is defined as time from randomization to disease recurrence or death, whichever occurred first. Patients who are still alive are censored at the last date of known free of recurrence.
Outcome measures
| Measure |
Arm A (Everolimus)
n=2 Participants
Patients receive everolimus PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
everolimus: Given PO
|
Arm B (Placebo)
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
|
|---|---|---|
|
Disease Free Survival (DFS)
|
1.3 years
There are only 2 patients on this study, and the confidence interval for the median can not be calculated. Full range would reveal patient individual data.
|
—
|
SECONDARY outcome
Timeframe: assessed every 3 months if < 2 years from study entry, and every 6 months up to 5 years from study entry or death, whichever occurred firstPopulation: All enrolled patients
OS is defined as time from randomization to death from any cause. Patients who are still alive are censored at the last date of known alive.
Outcome measures
| Measure |
Arm A (Everolimus)
n=2 Participants
Patients receive everolimus PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
everolimus: Given PO
|
Arm B (Placebo)
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
|
|---|---|---|
|
Overall Survival (OS)
|
2.05 years
There are only 2 patients on this study, and the confidence interval for the median can not be calculated.Full range would reveal patient individual data.
|
—
|
Adverse Events
Arm A (Everolimus)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Arm B (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Everolimus)
n=2 participants at risk
Patients receive everolimus PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
everolimus: Given PO
|
Arm B (Placebo)
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
|
|---|---|---|
|
Investigations
Aspartate aminotransferase increase
|
50.0%
1/2 • Adverse events were assessed at the end of each cycle (1 cycle=4 weeks) and at 30 days after the completion of protocol therapy
Only grades 4-5 hematologic events and grades 3-5 non-hematologic events were reportable on this study.
|
—
0/0 • Adverse events were assessed at the end of each cycle (1 cycle=4 weeks) and at 30 days after the completion of protocol therapy
Only grades 4-5 hematologic events and grades 3-5 non-hematologic events were reportable on this study.
|
|
Investigations
Neutrophil count decrease
|
50.0%
1/2 • Adverse events were assessed at the end of each cycle (1 cycle=4 weeks) and at 30 days after the completion of protocol therapy
Only grades 4-5 hematologic events and grades 3-5 non-hematologic events were reportable on this study.
|
—
0/0 • Adverse events were assessed at the end of each cycle (1 cycle=4 weeks) and at 30 days after the completion of protocol therapy
Only grades 4-5 hematologic events and grades 3-5 non-hematologic events were reportable on this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place