Trial Outcomes & Findings for Pilot Study of mTOR Inhibitor Therapy in Peutz-Jeghers Syndrome (NCT NCT00811590)

NCT ID: NCT00811590

Last Updated: 2024-09-19

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

24 months

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure
All Patients
All patients enrolled/eligible.
Overall Study
STARTED
3
Overall Study
COMPLETED
3
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of mTOR Inhibitor Therapy in Peutz-Jeghers Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Patients
n=3 Participants
All patients enrolled/eligible.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
34.6667 years
STANDARD_DEVIATION 18.71719 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Region of Enrollment
United States
3 participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Due to small enrollment number, analysis was not possible.

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Randall Burt

Huntsman Cancer Institute

Phone: 801-585-3281

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place