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A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers (GI-NETorPNET)

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ClinicalTrials.gov Identifier: NCT02132468
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : October 19, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Mateon Therapeutics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neuroendocrine Tumors
Intervention Drug: fosbretabulin tromethamine
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fosbretabulin Tromethamine
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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

Period Title: Overall Study
Started 18
Completed 11
Not Completed 7
Arm/Group Title Fosbretabulin Tromethamine
Hide Arm/Group Description

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 Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
57.8  (9.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
9
  50.0%
Male
9
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  11.1%
White
16
  88.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants With Improved, Stable, or Worsened Change In Chromogranin A (CgA) Biomarker Levels From Baseline
Hide Description 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%.
Time Frame Baseline and 4 months
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Safety Population
Arm/Group Title Fosbretabulin Tromethamine
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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 Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Improved
1
   5.6%
Stable
11
  61.1%
Worsened
6
  33.3%
2.Primary Outcome
Title Number of Participants With Improved, Stable, or Worsened Change In 5-hydroxyindoleacetic Acid (5-HIAA) Biomarker Levels From Baseline
Hide Description 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%.
Time Frame Baseline and 4 months
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Hide Analysis Population Description
Participants who had 5-hydroxyindoleacetic acid (5-HIAA) biomaker sample taken at baseline and at 4 months.
Arm/Group Title Fosbretabulin Tromethamine
Hide Arm/Group Description:

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 Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Improved
2
  15.4%
Stable
8
  61.5%
Worsened
3
  23.1%
3.Primary Outcome
Title Number of Participants With Improved, Stable, or Worsened Change In Serotonin Biomarker Levels From Baseline
Hide Description 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%.
Time Frame Baseline and 4 months
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Hide Analysis Population Description
Participants who had serotonin biomaker samples taken at baseline and at 4 months.
Arm/Group Title Fosbretabulin Tromethamine
Hide Arm/Group Description:

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 Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Improved
0
   0.0%
Stable
10
  83.3%
Worsened
2
  16.7%
4.Secondary Outcome
Title Number of Participants With Partial Response (PR), Progressive Disease (PD), or Stable Disease (SD) Based on RECIST 1.1
Hide Description 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.
Time Frame Baseline and 4 months
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Modified Intent-to-Treat
Arm/Group Title Fosbretabulin Tromethamine
Hide Arm/Group Description:

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 Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
1
   7.1%
Stable Disease
7
  50.0%
Progressive Disease
6
  42.9%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fosbretabulin Tromethamine
Hide Arm/Group Description

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

All-Cause Mortality
Fosbretabulin Tromethamine
Affected / at Risk (%)
Total   1/18 (5.56%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fosbretabulin Tromethamine
Affected / at Risk (%)
Total   2/18 (11.11%) 
Endocrine disorders   
Carcinoid Syndrome  1  1/18 (5.56%) 
Infections and infestations   
Pneumonia  1  1/18 (5.56%) 
Urosepsis  1  1/18 (5.56%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fosbretabulin Tromethamine
Affected / at Risk (%)
Total   18/18 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  4/18 (22.22%) 
Leukaemoid reaction  1  1/18 (5.56%) 
Leukopenia  1  1/18 (5.56%) 
Thrombocytopenia  1  1/18 (5.56%) 
Cardiac disorders   
Palpitations  1  1/18 (5.56%) 
Ear and labyrinth disorders   
Tinnitus  1  1/18 (5.56%) 
Endocrine disorders   
Carcinoid Syndrome  1  1/18 (5.56%) 
Eye disorders   
Conjunctivitis Allergic  1  1/18 (5.56%) 
Macular fibrosis  1  1/18 (5.56%) 
vision blurred  1  1/18 (5.56%) 
Gastrointestinal disorders   
abdominal discomfort  1  1/18 (5.56%) 
abdominal distension  1  1/18 (5.56%) 
abdominal pain  1  7/18 (38.89%) 
abdominal pain upper  1  1/18 (5.56%) 
anal pruritus  1  1/18 (5.56%) 
ascites  1  1/18 (5.56%) 
constipation  1  3/18 (16.67%) 
diarrhoea  1  4/18 (22.22%) 
dyspepsia  1  1/18 (5.56%) 
epigastric discomfort  1  1/18 (5.56%) 
flatulence  1  2/18 (11.11%) 
eructation  1  1/18 (5.56%) 
frequent bowel movements  1  2/18 (11.11%) 
gastrointestinal pain  1  1/18 (5.56%) 
gastrooesophageal reflux disease  1  1/18 (5.56%) 
hypoaesthesia oral  1  1/18 (5.56%) 
nausea  1  6/18 (33.33%) 
vomiting  1  4/18 (22.22%) 
General disorders   
breakthrough pain  1  1/18 (5.56%) 
chest pain  1  2/18 (11.11%) 
chills  1  3/18 (16.67%) 
early satiety  1  1/18 (5.56%) 
fatigue  1  11/18 (61.11%) 
feeling jittery  1  1/18 (5.56%) 
injection site bruising  1  1/18 (5.56%) 
local swelling  1  1/18 (5.56%) 
non-cardiac chest pain  1  1/18 (5.56%) 
oedema peripheral  1  4/18 (22.22%) 
pyrexia  1  4/18 (22.22%) 
Hepatobiliary disorders   
hepatic failure  1  1/18 (5.56%) 
Infections and infestations   
Oral herpes  1  1/18 (5.56%) 
Pneumonia  1  1/18 (5.56%) 
upper respiratory tract infection  1  1/18 (5.56%) 
urinary tract infection  1  5/18 (27.78%) 
urosepsis  1  1/18 (5.56%) 
Injury, poisoning and procedural complications   
infusion related reaction  1  3/18 (16.67%) 
upper limb fracture  1  1/18 (5.56%) 
Investigations   
alanine aminotransferase increased  1  6/18 (33.33%) 
aspartate aminotransferase increased  1  6/18 (33.33%) 
blood alkaline phosphatase increased  1  3/18 (16.67%) 
blood creatinine increased  1  1/18 (5.56%) 
blood magnesium increased  1  1/18 (5.56%) 
weight decreased  1  1/18 (5.56%) 
white blood cell count increased  1  1/18 (5.56%) 
Metabolism and nutrition disorders   
decreased appetite  1  3/18 (16.67%) 
dehydration  1  2/18 (11.11%) 
diabetes mellitus  1  1/18 (5.56%) 
hyperglycemia  1  1/18 (5.56%) 
hyperkalaemia  1  1/18 (5.56%) 
hypoalbuminaemia  1  3/18 (16.67%) 
hypocalcaemia  1  1/18 (5.56%) 
hypokalaemia  1  3/18 (16.67%) 
hypomagnesaemia  1  3/18 (16.67%) 
hypophosphataemia  1  1/18 (5.56%) 
hypovolaemia  1  1/18 (5.56%) 
metabolic acidosis  1  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders   
arthralgia  1  1/18 (5.56%) 
back pain  1  7/18 (38.89%) 
bone pain  1  2/18 (11.11%) 
connective tissue disorder  1  1/18 (5.56%) 
flank pain  1  3/18 (16.67%) 
muscle spasms  1  1/18 (5.56%) 
muscular weakness  1  1/18 (5.56%) 
musculoskeletal pain  1  1/18 (5.56%) 
myalgia  1  1/18 (5.56%) 
neck pain  1  2/18 (11.11%) 
pain in jaw  1  1/18 (5.56%) 
Nervous system disorders   
cranial nerve disorder  1  1/18 (5.56%) 
dizziness  1  1/18 (5.56%) 
encephalopathy  1  1/18 (5.56%) 
headache  1  3/18 (16.67%) 
migraine  1  1/18 (5.56%) 
neuralgia  1  1/18 (5.56%) 
neuropathy peripheral  1  3/18 (16.67%) 
paraesthesia  1  4/18 (22.22%) 
restless leg syndrome  1  2/18 (11.11%) 
tremor  1  1/18 (5.56%) 
Psychiatric disorders   
anxiety  1  1/18 (5.56%) 
depression  1  1/18 (5.56%) 
Renal and urinary disorders   
dysuria  1  1/18 (5.56%) 
polyuria  1  1/18 (5.56%) 
proteinuria  1  1/18 (5.56%) 
renal failure  1  1/18 (5.56%) 
renal failure acute  1  1/18 (5.56%) 
urinary retention  1  1/18 (5.56%) 
Reproductive system and breast disorders   
prostatitis  1  1/18 (5.56%) 
pruritis genital  1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
cough  1  2/18 (11.11%) 
dysphonia  1  1/18 (5.56%) 
dyspnoea  1  4/18 (22.22%) 
dyspnoea exertional  1  1/18 (5.56%) 
hypoxia  1  1/18 (5.56%) 
respiratory failure  1  1/18 (5.56%) 
Skin and subcutaneous tissue disorders   
blister  1  1/18 (5.56%) 
hyperhydrosis  1  1/18 (5.56%) 
night sweats  1  5/18 (27.78%) 
pruritis  1  5/18 (27.78%) 
pruritis generalised  1  1/18 (5.56%) 
rash  1  2/18 (11.11%) 
rosacea  1  1/18 (5.56%) 
Vascular disorders   
flushing  1  4/18 (22.22%) 
hypertension  1  3/18 (16.67%) 
hypotension  1  4/18 (22.22%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Operations
Organization: Mateon Therapeutics
Phone: 6506357000
EMail: ca@mateon.com
Layout table for additonal information
Responsible Party: Mateon Therapeutics
ClinicalTrials.gov Identifier: NCT02132468     History of Changes
Other Study ID Numbers: OX4218s
First Submitted: May 2, 2014
First Posted: May 7, 2014
Results First Submitted: September 21, 2017
Results First Posted: October 19, 2017
Last Update Posted: December 5, 2017