Trial Outcomes & Findings for Phase II Study of Everolimus Beyond Progression (NCT NCT02269670)
NCT ID: NCT02269670
Last Updated: 2022-04-05
Results Overview
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
TERMINATED
PHASE2
3 participants
Up to 2 years
2022-04-05
Participant Flow
Participant milestones
| Measure |
Treatment (Everolimus, Hormone Therapy)
Patients receive everolimus PO daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant IM or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO QID; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.
everolimus: Given PO
anastrozole: Given PO
letrozole: Given PO
tamoxifen citrate: Given PO
fulvestrant: Given IM or PO
megestrol acetate: Given PO
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Everolimus, Hormone Therapy)
Patients receive everolimus PO daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant IM or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO QID; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.
everolimus: Given PO
anastrozole: Given PO
letrozole: Given PO
tamoxifen citrate: Given PO
fulvestrant: Given IM or PO
megestrol acetate: Given PO
|
|---|---|
|
Overall Study
All subjects have not completed all research related interventions
|
3
|
Baseline Characteristics
Phase II Study of Everolimus Beyond Progression
Baseline characteristics by cohort
| Measure |
Treatment (Everolimus, Hormone Therapy)
n=3 Participants
Patients receive everolimus PO daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant IM or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO QID; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.
everolimus: Given PO
anastrozole: Given PO
letrozole: Given PO
tamoxifen citrate: Given PO
fulvestrant: Given IM or PO
megestrol acetate: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the initiation of alternate hormonal treatment in combination with everolimus to time of death from any cause, assessed up to 2 yearsPopulation: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Everolimus, Hormone Therapy)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Everolimus, Hormone Therapy)
n=3 participants at risk
Patients receive everolimus PO daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant IM or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO QID; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.
everolimus: Given PO
anastrozole: Given PO
letrozole: Given PO
tamoxifen citrate: Given PO
fulvestrant: Given IM or PO
megestrol acetate: Given PO
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hypertension
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Investigations
Investigations - Other, specify
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place