Trial Outcomes & Findings for A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers (NCT NCT02132468)
NCT ID: NCT02132468
Last Updated: 2017-12-05
Results Overview
The mean change from baseline in chromogranin A (CgA) biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline and 4 months
Results posted on
2017-12-05
Participant Flow
Participant milestones
| Measure |
Fosbretabulin Tromethamine
Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles
fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers
Baseline characteristics by cohort
| Measure |
Fosbretabulin Tromethamine
n=18 Participants
Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles
fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity
|
|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsPopulation: Safety Population
The mean change from baseline in chromogranin A (CgA) biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.
Outcome measures
| Measure |
Fosbretabulin Tromethamine
n=18 Participants
Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles
fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity
|
|---|---|
|
Number of Participants With Improved, Stable, or Worsened Change In Chromogranin A (CgA) Biomarker Levels From Baseline
Improved
|
1 Participants
|
|
Number of Participants With Improved, Stable, or Worsened Change In Chromogranin A (CgA) Biomarker Levels From Baseline
Stable
|
11 Participants
|
|
Number of Participants With Improved, Stable, or Worsened Change In Chromogranin A (CgA) Biomarker Levels From Baseline
Worsened
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsPopulation: Participants who had 5-hydroxyindoleacetic acid (5-HIAA) biomaker sample taken at baseline and at 4 months.
The mean change from baseline in 5-hydroxyindoleacetic acid (5-HIAA) biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.
Outcome measures
| Measure |
Fosbretabulin Tromethamine
n=13 Participants
Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles
fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity
|
|---|---|
|
Number of Participants With Improved, Stable, or Worsened Change In 5-hydroxyindoleacetic Acid (5-HIAA) Biomarker Levels From Baseline
Improved
|
2 Participants
|
|
Number of Participants With Improved, Stable, or Worsened Change In 5-hydroxyindoleacetic Acid (5-HIAA) Biomarker Levels From Baseline
Stable
|
8 Participants
|
|
Number of Participants With Improved, Stable, or Worsened Change In 5-hydroxyindoleacetic Acid (5-HIAA) Biomarker Levels From Baseline
Worsened
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsPopulation: Participants who had serotonin biomaker samples taken at baseline and at 4 months.
The mean change from baseline in serotonin biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.
Outcome measures
| Measure |
Fosbretabulin Tromethamine
n=12 Participants
Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles
fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity
|
|---|---|
|
Number of Participants With Improved, Stable, or Worsened Change In Serotonin Biomarker Levels From Baseline
Improved
|
0 Participants
|
|
Number of Participants With Improved, Stable, or Worsened Change In Serotonin Biomarker Levels From Baseline
Stable
|
10 Participants
|
|
Number of Participants With Improved, Stable, or Worsened Change In Serotonin Biomarker Levels From Baseline
Worsened
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and 4 monthsPopulation: Modified Intent-to-Treat
The objective response rate (complete response, partial response, progressive disease, or stable disease) was determined by the investigator assessment of the participant's CT or MRI using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) for target lesions. Partial Response (PR) is when there is at least 30% decrease in sum of the longest diameter of the target lesions. Progressive Disease (PD) is when there is at least 20% increase in the sum of the longest diameter of the target lesions, as well as an absolute increase of at least 5 mm (including appearance of new lesions). Stable Disease (SD) is when there neither a PR nor PD is noted.
Outcome measures
| Measure |
Fosbretabulin Tromethamine
n=14 Participants
Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles
fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity
|
|---|---|
|
Number of Participants With Partial Response (PR), Progressive Disease (PD), or Stable Disease (SD) Based on RECIST 1.1
Partial Response
|
1 Participants
|
|
Number of Participants With Partial Response (PR), Progressive Disease (PD), or Stable Disease (SD) Based on RECIST 1.1
Stable Disease
|
7 Participants
|
|
Number of Participants With Partial Response (PR), Progressive Disease (PD), or Stable Disease (SD) Based on RECIST 1.1
Progressive Disease
|
6 Participants
|
Adverse Events
Fosbretabulin Tromethamine
Serious events: 2 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Fosbretabulin Tromethamine
n=18 participants at risk
Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles
fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity
|
|---|---|
|
Endocrine disorders
Carcinoid Syndrome
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
Urosepsis
|
5.6%
1/18 • 1 year
|
Other adverse events
| Measure |
Fosbretabulin Tromethamine
n=18 participants at risk
Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles
fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
4/18 • 1 year
|
|
Blood and lymphatic system disorders
Leukaemoid reaction
|
5.6%
1/18 • 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.6%
1/18 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
1/18 • 1 year
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
1/18 • 1 year
|
|
Endocrine disorders
Carcinoid Syndrome
|
5.6%
1/18 • 1 year
|
|
Eye disorders
Conjunctivitis Allergic
|
5.6%
1/18 • 1 year
|
|
Eye disorders
Macular fibrosis
|
5.6%
1/18 • 1 year
|
|
Eye disorders
vision blurred
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
abdominal discomfort
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
abdominal distension
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
abdominal pain
|
38.9%
7/18 • 1 year
|
|
Gastrointestinal disorders
abdominal pain upper
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
anal pruritus
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
ascites
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
constipation
|
16.7%
3/18 • 1 year
|
|
Gastrointestinal disorders
diarrhoea
|
22.2%
4/18 • 1 year
|
|
Gastrointestinal disorders
dyspepsia
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
epigastric discomfort
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
flatulence
|
11.1%
2/18 • 1 year
|
|
Gastrointestinal disorders
eructation
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
frequent bowel movements
|
11.1%
2/18 • 1 year
|
|
Gastrointestinal disorders
gastrointestinal pain
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
hypoaesthesia oral
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
nausea
|
33.3%
6/18 • 1 year
|
|
Gastrointestinal disorders
vomiting
|
22.2%
4/18 • 1 year
|
|
General disorders
breakthrough pain
|
5.6%
1/18 • 1 year
|
|
General disorders
chest pain
|
11.1%
2/18 • 1 year
|
|
General disorders
chills
|
16.7%
3/18 • 1 year
|
|
General disorders
early satiety
|
5.6%
1/18 • 1 year
|
|
General disorders
fatigue
|
61.1%
11/18 • 1 year
|
|
General disorders
feeling jittery
|
5.6%
1/18 • 1 year
|
|
General disorders
injection site bruising
|
5.6%
1/18 • 1 year
|
|
General disorders
local swelling
|
5.6%
1/18 • 1 year
|
|
General disorders
non-cardiac chest pain
|
5.6%
1/18 • 1 year
|
|
General disorders
oedema peripheral
|
22.2%
4/18 • 1 year
|
|
General disorders
pyrexia
|
22.2%
4/18 • 1 year
|
|
Hepatobiliary disorders
hepatic failure
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
Oral herpes
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
upper respiratory tract infection
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
urinary tract infection
|
27.8%
5/18 • 1 year
|
|
Infections and infestations
urosepsis
|
5.6%
1/18 • 1 year
|
|
Injury, poisoning and procedural complications
infusion related reaction
|
16.7%
3/18 • 1 year
|
|
Injury, poisoning and procedural complications
upper limb fracture
|
5.6%
1/18 • 1 year
|
|
Investigations
alanine aminotransferase increased
|
33.3%
6/18 • 1 year
|
|
Investigations
aspartate aminotransferase increased
|
33.3%
6/18 • 1 year
|
|
Investigations
blood alkaline phosphatase increased
|
16.7%
3/18 • 1 year
|
|
Investigations
blood creatinine increased
|
5.6%
1/18 • 1 year
|
|
Investigations
blood magnesium increased
|
5.6%
1/18 • 1 year
|
|
Investigations
weight decreased
|
5.6%
1/18 • 1 year
|
|
Investigations
white blood cell count increased
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
decreased appetite
|
16.7%
3/18 • 1 year
|
|
Metabolism and nutrition disorders
dehydration
|
11.1%
2/18 • 1 year
|
|
Metabolism and nutrition disorders
diabetes mellitus
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
hyperglycemia
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
hypoalbuminaemia
|
16.7%
3/18 • 1 year
|
|
Metabolism and nutrition disorders
hypocalcaemia
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
hypokalaemia
|
16.7%
3/18 • 1 year
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
16.7%
3/18 • 1 year
|
|
Metabolism and nutrition disorders
hypophosphataemia
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
hypovolaemia
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
metabolic acidosis
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
back pain
|
38.9%
7/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
11.1%
2/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
connective tissue disorder
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
16.7%
3/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
11.1%
2/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
pain in jaw
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
cranial nerve disorder
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
dizziness
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
encephalopathy
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
headache
|
16.7%
3/18 • 1 year
|
|
Nervous system disorders
migraine
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
neuralgia
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
neuropathy peripheral
|
16.7%
3/18 • 1 year
|
|
Nervous system disorders
paraesthesia
|
22.2%
4/18 • 1 year
|
|
Nervous system disorders
restless leg syndrome
|
11.1%
2/18 • 1 year
|
|
Nervous system disorders
tremor
|
5.6%
1/18 • 1 year
|
|
Psychiatric disorders
anxiety
|
5.6%
1/18 • 1 year
|
|
Psychiatric disorders
depression
|
5.6%
1/18 • 1 year
|
|
Renal and urinary disorders
dysuria
|
5.6%
1/18 • 1 year
|
|
Renal and urinary disorders
polyuria
|
5.6%
1/18 • 1 year
|
|
Renal and urinary disorders
proteinuria
|
5.6%
1/18 • 1 year
|
|
Renal and urinary disorders
renal failure
|
5.6%
1/18 • 1 year
|
|
Renal and urinary disorders
renal failure acute
|
5.6%
1/18 • 1 year
|
|
Renal and urinary disorders
urinary retention
|
5.6%
1/18 • 1 year
|
|
Reproductive system and breast disorders
prostatitis
|
5.6%
1/18 • 1 year
|
|
Reproductive system and breast disorders
pruritis genital
|
5.6%
1/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
11.1%
2/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
dysphonia
|
5.6%
1/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
22.2%
4/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea exertional
|
5.6%
1/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
5.6%
1/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
5.6%
1/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
blister
|
5.6%
1/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
hyperhydrosis
|
5.6%
1/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
night sweats
|
27.8%
5/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
pruritis
|
27.8%
5/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
pruritis generalised
|
5.6%
1/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
rash
|
11.1%
2/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
rosacea
|
5.6%
1/18 • 1 year
|
|
Vascular disorders
flushing
|
22.2%
4/18 • 1 year
|
|
Vascular disorders
hypertension
|
16.7%
3/18 • 1 year
|
|
Vascular disorders
hypotension
|
22.2%
4/18 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60