Trial Outcomes & Findings for Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma (NCT NCT00856050)
NCT ID: NCT00856050
Last Updated: 2017-04-18
Results Overview
Data below are reported as progression free rate (%).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-04-18
Participant Flow
27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.
Participant milestones
| Measure |
Letrozole
Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
Baseline characteristics by cohort
| Measure |
Letrozole
n=26 Participants
letrozole 2.5mg by mouth per day
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.
Data below are reported as progression free rate (%).
Outcome measures
| Measure |
Letrozole
n=26 Participants
letrozole 2.5mg by mouth per day
|
|---|---|
|
Progression Free Survival Rate at 12 Weeks
|
46 percentage of participants
Interval 29.0 to 64.0
|
Adverse Events
Letrozole
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Letrozole
n=26 participants at risk
Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
|
|---|---|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
8.0%
2/25
|
|
Gastrointestinal disorders
Nausea
|
16.0%
4/25
|
|
General disorders
Fatigue
|
16.0%
4/25
|
|
Musculoskeletal and connective tissue disorders
Joint= pain
|
20.0%
5/25
|
|
Musculoskeletal and connective tissue disorders
Muscle= pain
|
28.0%
7/25
|
|
Vascular disorders
Hot flashes
|
68.0%
17/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place