Trial Outcomes & Findings for Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer (NCT NCT00379197)
NCT ID: NCT00379197
Last Updated: 2017-12-28
Results Overview
A response is the number of participants whose tumor demonstrated a decrease in FDG uptake (SUV) by 50% or greater in at least one of the metastatic sites as measured by PET imaging at the end of 4 weeks of treatment compared to baseline.
TERMINATED
PHASE2
13 participants
Week 4
2017-12-28
Participant Flow
Participant milestones
| Measure |
Naltrexone
Naltrexone 50 mg taken orally once daily for 2 28-day cycles with an option to continue on Naltrexone at the discretion of the treating physician.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Naltrexone
n=8 Participants
Naltrexone hydrochloride 50 mg will be taken once a day every day of a 28 day treatment course. Positron-emission tomography (PET) / computed tomography (CT) given with injection of 2-Deoxy-2-\[18F\]fluoro-D-Glucose (FDG).
naltrexone hydrochloride: Naltrexone should be taken with water or food, and it can be taken at any time day. Naltrexone 50 mg will be taken once a day every day of a 28 day treatment course.
Positron-emission tomography (PET) / computed tomography (CT): Given with injection of 2-Deoxy-2-\[18F\]fluoro-D-Glucose (FDG). Follow-up scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female only
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4A response is the number of participants whose tumor demonstrated a decrease in FDG uptake (SUV) by 50% or greater in at least one of the metastatic sites as measured by PET imaging at the end of 4 weeks of treatment compared to baseline.
Outcome measures
| Measure |
Naltrexone Treatment
n=8 Participants
Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed as baseline level at the beginning of study and after the completion of cycle 1 and cycle 2.
|
|---|---|
|
Disease Response
|
1 participants
|
SECONDARY outcome
Timeframe: From Baseline to 1 YearPopulation: One of the 8 participants did not have an increase in SUV above baseline at 8 weeks, but no further PET scans were performed after 8 weeks. The reported median value is for the remaining 7 participants.
First time when maximum SUV is higher than that at baseline within 1 year of study entry.
Outcome measures
| Measure |
Naltrexone Treatment
n=7 Participants
Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed as baseline level at the beginning of study and after the completion of cycle 1 and cycle 2.
|
|---|---|
|
Median Time to Event
|
8 weeks
Interval 4.0 to 8.0
|
Adverse Events
Naltrexone Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone Treatment
n=8 participants at risk
Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up compared to the baseline level of FDG uptake.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Pain right axillary node
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Pancytopenia
|
12.5%
1/8
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8
|
|
Gastrointestinal disorders
Abdominal bloating
|
12.5%
1/8
|
|
Gastrointestinal disorders
right upper quadrant abdominal pain
|
12.5%
1/8
|
|
Gastrointestinal disorders
increased thirst
|
12.5%
1/8
|
|
Gastrointestinal disorders
Ascites
|
12.5%
1/8
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8
|
|
Hepatobiliary disorders
Cirrhotic Appearing Liver
|
12.5%
1/8
|
|
Investigations
Weight Gain
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
pain - muscular
|
12.5%
1/8
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Itching
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
mild erythema
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
hand and foot syndrome
|
12.5%
1/8
|
|
Vascular disorders
Hot Flashes
|
12.5%
1/8
|
Additional Information
Dr. Douglas Yee, MD
University of Minnesota, Dept. Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place