Trial Outcomes & Findings for A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant (NCT NCT02540330)

NCT ID: NCT02540330

Last Updated: 2024-04-03

Results Overview

Number of adverse events per CTCAE v4.0 after treatment with fulvestrant by route of administration

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Up to 4 weeks

Results posted on

2024-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Intramuscular Fulvestrant 500mg fulvestrant administered intramuscularly Fulvestrant	Intraductal Fulvestrant up to 500mg fulvestrant administered intraductally Fulvestrant
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intramuscular Fulvestrant n=2 Participants 500mg fulvestrant administered intramuscularly Fulvestrant	Intraductal Fulvestrant n=1 Participants up to 500mg fulvestrant administered intraductally Fulvestrant	Total n=3 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	45 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Number of adverse events per CTCAE v4.0 after treatment with fulvestrant by route of administration

Outcome measures

Outcome measures
Measure	Intramuscular Route n=2 Participants 500mg fulvestrant	Intraductal Route n=1 Participants up to 500mg fulvestrant
Safety and Tolerability of Two Delivery Methods	1 Participants	0 Participants

Adverse Events

Intramuscular Fulvestrant

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Intraductal Fulvestrant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intramuscular Fulvestrant n=2 participants at risk 500mg fulvestrant administered intramuscularly Fulvestrant	Intraductal Fulvestrant n=1 participants at risk up to 500mg fulvestrant administered intraductally Fulvestrant
Musculoskeletal and connective tissue disorders Pain	50.0% 1/2 • Number of events 2 • Up to 50 days	0.00% 0/1 • Up to 50 days

Additional Information

Heather Fraser, VP Clinical, Regulatory & CMC

Atossa Therapeutics, Inc.

Phone: 206-707-3088

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place