Trial Outcomes & Findings for A Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression (NCT NCT01259869)
NCT ID: NCT01259869
Last Updated: 2023-08-22
Results Overview
Assessed by evaluation of change in product of bidimensional measurement of enhancing brain tumour on CT scan or MRI
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
18 months
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
PX-866
PX-866: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
PX-866
PX-866: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
|
|---|---|
|
Overall Study
Duplicated registration
|
1
|
Baseline Characteristics
A Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression
Baseline characteristics by cohort
| Measure |
PX-866
n=33 Participants
PX-866: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
|
|---|---|
|
Age, Continuous
|
56 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
Canada
|
33 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All patients completed study
Assessed by evaluation of change in product of bidimensional measurement of enhancing brain tumour on CT scan or MRI
Outcome measures
| Measure |
PX-866
n=33 Participants
PX-866: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
|
|---|---|
|
Objective Response Rate
|
1 Participants
|
Adverse Events
PX-866
Serious events: 9 serious events
Other events: 33 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
PX-866
n=33 participants at risk
PX-866: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Number of events 1 • 18 months
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Number of events 1 • 18 months
|
|
Investigations
Alanine aminotransferase increased
|
3.0%
1/33 • Number of events 1 • 18 months
|
|
Investigations
Aspartate aminotransferase increase
|
3.0%
1/33 • Number of events 1 • 18 months
|
|
Vascular disorders
Thromboembolic event
|
6.1%
2/33 • Number of events 2 • 18 months
|
|
Nervous system disorders
Seizure
|
9.1%
3/33 • Number of events 3 • 18 months
|
|
Eye disorders
Eye pain
|
3.0%
1/33 • Number of events 1 • 18 months
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.0%
1/33 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
6.1%
2/33 • Number of events 2 • 18 months
|
|
General disorders
Death NOS
|
3.0%
1/33 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
PX-866
n=33 participants at risk
PX-866: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
|
|---|---|
|
Nervous system disorders
Peripheral motor neuropathy
|
12.1%
4/33 • 18 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.1%
3/33 • 18 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.1%
2/33 • 18 months
|
|
Ear and labyrinth disorders
Tinnitus
|
6.1%
2/33 • 18 months
|
|
Endocrine disorders
Cushingoid
|
6.1%
2/33 • 18 months
|
|
Eye disorders
Blurred vision
|
15.2%
5/33 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
18.2%
6/33 • 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
39.4%
13/33 • 18 months
|
|
Gastrointestinal disorders
Dyspepsia
|
21.2%
7/33 • 18 months
|
|
Gastrointestinal disorders
Mucositis oral
|
6.1%
2/33 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
63.6%
21/33 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
45.5%
15/33 • 18 months
|
|
General disorders
Death NOS
|
6.1%
2/33 • 18 months
|
|
General disorders
Edema limbs
|
12.1%
4/33 • 18 months
|
|
General disorders
Fatigue
|
69.7%
23/33 • 18 months
|
|
General disorders
Gait disturbance
|
6.1%
2/33 • 18 months
|
|
Hepatobiliary disorders
Urinary tract infection
|
6.1%
2/33 • 18 months
|
|
Metabolism and nutrition disorders
Anorexia
|
15.2%
5/33 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
3/33 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
3/33 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.1%
2/33 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
9.1%
3/33 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
12.1%
4/33 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
9.1%
3/33 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
3/33 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.2%
5/33 • 18 months
|
|
Nervous system disorders
Ataxia
|
9.1%
3/33 • 18 months
|
|
Nervous system disorders
Concentration impairment
|
6.1%
2/33 • 18 months
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33 • 18 months
|
|
Nervous system disorders
Dysarthria
|
9.1%
3/33 • 18 months
|
|
Nervous system disorders
Dysgeusia
|
9.1%
3/33 • 18 months
|
|
Nervous system disorders
Dysphasia
|
27.3%
9/33 • 18 months
|
|
Nervous system disorders
Facial nerve disorder
|
9.1%
3/33 • 18 months
|
|
Nervous system disorders
Headache
|
63.6%
21/33 • 18 months
|
|
Nervous system disorders
Memory impairment
|
12.1%
4/33 • 18 months
|
|
Nervous system disorders
Pyramidal tract syndrome
|
18.2%
6/33 • 18 months
|
|
Nervous system disorders
Seizure
|
33.3%
11/33 • 18 months
|
|
Nervous system disorders
Tremor
|
6.1%
2/33 • 18 months
|
|
Nervous system disorders
Other nervous system disorders
|
18.2%
6/33 • 18 months
|
|
Psychiatric disorders
Anxiety
|
21.2%
7/33 • 18 months
|
|
Psychiatric disorders
Confusion
|
9.1%
3/33 • 18 months
|
|
Psychiatric disorders
Depression
|
21.2%
7/33 • 18 months
|
|
Psychiatric disorders
Insomnia
|
30.3%
10/33 • 18 months
|
|
Renal and urinary disorders
Urinary frequency
|
6.1%
2/33 • 18 months
|
|
Renal and urinary disorders
Urinary incontinence
|
6.1%
2/33 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
5/33 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
3/33 • 18 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.1%
2/33 • 18 months
|
|
Vascular disorders
Flushing
|
9.1%
3/33 • 18 months
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • 18 months
|
|
Vascular disorders
Thromboembolic event
|
6.1%
2/33 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place