Trial Outcomes & Findings for Palliative Management of Inoperable Malignant Bowel Obstruction (NCT NCT04027348)
NCT ID: NCT04027348
Last Updated: 2022-11-29
Results Overview
The primary efficacy endpoint is the proportion of eligible patients whose malignant bowel obstruction clears (de-obstruction) within 7 days of starting the protocol therapy. Patients meeting de-obstruction criteria within 7 days will be deemed treatment successes. De-obstruction is defined as: * Effective introduction of oral intake (yes/no) * Distinguished from small volumes of oral fluid that may be allowed with unresolved MBO * Tolerating oral liquid diet (day 1 of de-obstruction) that is able to be progressively more solid (oral or enteral) * Cessation of vomiting or ability for NGT or venting G tube to remain clamped without vomiting Rate of de-obstruction is defined as: \- From the date of study enrollment to the first observation of de-obstruction.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Within 7 days of starting protocol therapy
Results posted on
2022-11-29
Participant Flow
Participant milestones
| Measure |
Treatment (Octreotide, Dexamethasone, Metoclopramide)
IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.
Dexamethasone: Given IV
Metoclopramide: Given IV
Octreotide: Given IV
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Octreotide, Dexamethasone, Metoclopramide)
IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.
Dexamethasone: Given IV
Metoclopramide: Given IV
Octreotide: Given IV
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Palliative Management of Inoperable Malignant Bowel Obstruction
Baseline characteristics by cohort
| Measure |
Treatment (Octreotide, Dexamethasone, Metoclopramide)
n=15 Participants
IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.
Dexamethasone: Given IV
Metoclopramide: Given IV
Octreotide: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
|
Performance Status
|
64.7 units on a scale
STANDARD_DEVIATION 18.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days of starting protocol therapyPopulation: 2 Patients did not complete treatment and were not evaluated for de-obstruction (due to AEs).
The primary efficacy endpoint is the proportion of eligible patients whose malignant bowel obstruction clears (de-obstruction) within 7 days of starting the protocol therapy. Patients meeting de-obstruction criteria within 7 days will be deemed treatment successes. De-obstruction is defined as: * Effective introduction of oral intake (yes/no) * Distinguished from small volumes of oral fluid that may be allowed with unresolved MBO * Tolerating oral liquid diet (day 1 of de-obstruction) that is able to be progressively more solid (oral or enteral) * Cessation of vomiting or ability for NGT or venting G tube to remain clamped without vomiting Rate of de-obstruction is defined as: \- From the date of study enrollment to the first observation of de-obstruction.
Outcome measures
| Measure |
Treatment (Octreotide, Dexamethasone, Metoclopramide)
n=13 Participants
IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.
Dexamethasone: Given IV
Metoclopramide: Given IV
Octreotide: Given IV
|
|---|---|
|
Proportion of Patients With Obstruction Clearance
|
10 Participants
|
Adverse Events
Treatment (Octreotide, Dexamethasone, Metoclopramide)
Serious events: 6 serious events
Other events: 11 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Treatment (Octreotide, Dexamethasone, Metoclopramide)
n=15 participants at risk
IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.
Dexamethasone: Given IV
Metoclopramide: Given IV
Octreotide: Given IV
|
|---|---|
|
Gastrointestinal disorders
Obstruction gastric
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
20.0%
3/15 • Number of events 4 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
Other adverse events
| Measure |
Treatment (Octreotide, Dexamethasone, Metoclopramide)
n=15 participants at risk
IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.
Dexamethasone: Given IV
Metoclopramide: Given IV
Octreotide: Given IV
|
|---|---|
|
Cardiac disorders
Sinus bradycardia
|
13.3%
2/15 • Number of events 2 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Number of events 2 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
33.3%
5/15 • Number of events 6 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
General disorders
Edema limbs
|
20.0%
3/15 • Number of events 3 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
General disorders
Pain
|
13.3%
2/15 • Number of events 2 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Infections and infestations
Sepsis
|
13.3%
2/15 • Number of events 2 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Infections and infestations
Thrush
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
4/15 • Number of events 4 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Psychiatric disorders
Insomnia
|
20.0%
3/15 • Number of events 3 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
|
Gastrointestinal disorders
Obstruction gastric
|
6.7%
1/15 • Number of events 1 • From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place