Trial Outcomes & Findings for Cabozantinib-S-Malate in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer (NCT NCT01812668)
NCT ID: NCT01812668
Last Updated: 2021-08-05
Results Overview
Change in PET standard uptake value SUV levels (each value measured in g/ml). (post-treatment - pre-treatment)/pre-treatment x 100 , therefore, measured in percentage change from baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline to 4 weeks
Results posted on
2021-08-05
Participant Flow
Participant milestones
| Measure |
Treatment (Cabozantinib-s-malate)
Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
cabozantinib-s-malate: Given PO
fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan
positron emission tomography: Undergo 18F PET/FMAU PET scan
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cabozantinib-S-Malate in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Cabozantinib-s-malate)
n=20 Participants
Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
cabozantinib-s-malate: Given PO
fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan
positron emission tomography: Undergo 18F PET/FMAU PET scan
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 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
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksChange in PET standard uptake value SUV levels (each value measured in g/ml). (post-treatment - pre-treatment)/pre-treatment x 100 , therefore, measured in percentage change from baseline.
Outcome measures
| Measure |
Treatment (Cabozantinib-s-malate)
n=20 Participants
Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
cabozantinib-s-malate: Given PO
fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan
positron emission tomography: Undergo 18F PET/FMAU PET scan
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Change in PET Standard Uptake Value SUV Levels Pre-treatment to Post-treatment.
|
-56 percentage change from baseline
Interval -85.0 to -5.0
|
SECONDARY outcome
Timeframe: From date of registration to date of first documented disease progression, or death from any cause, assessed up to 1 yearSummarized via the Kaplan-Meier (K-M) survivorship estimate.
Outcome measures
| Measure |
Treatment (Cabozantinib-s-malate)
n=20 Participants
Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
cabozantinib-s-malate: Given PO
fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan
positron emission tomography: Undergo 18F PET/FMAU PET scan
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Time to Progression
|
4.1 months
Interval 2.3 to 5.3
|
SECONDARY outcome
Timeframe: Up to 4 weeks post-treatment, about 2 years on average.Type of toxicities graded per National Cancer Institute (NCI) CTCAE version 4.0 Summarized via their frequency distribution and point estimate of the proportion.
Outcome measures
| Measure |
Treatment (Cabozantinib-s-malate)
n=20 Participants
Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
cabozantinib-s-malate: Given PO
fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan
positron emission tomography: Undergo 18F PET/FMAU PET scan
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
hypophosphatemia
|
2 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
increased AST
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
Parkinson like syndrome
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
UTI
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
anemia
|
2 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
decreased ALC
|
2 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
decreased platelet
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
dehydration
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
diarrhea
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
fatigue
|
3 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
foot blisters
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
hyperglycemia
|
2 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
hypertension
|
11 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
mandibular abscess
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
mucositis
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
pleurisy
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
pneumonia
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
urinary retention
|
1 Participants
|
|
Number of Participants With Indicated Toxicities Grade 3 or Higher
weight loss
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Patients with measurable disease
Number of Participants with Indicated Clinical response based on the RECIST criteria 1.1 summarized via their frequency distribution.
Outcome measures
| Measure |
Treatment (Cabozantinib-s-malate)
n=9 Participants
Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
cabozantinib-s-malate: Given PO
fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan
positron emission tomography: Undergo 18F PET/FMAU PET scan
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Participants With Indicated Clinical Response Based on the RECIST Criteria 1.1
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearSummarized via their frequency distribution, point estimate of the proportion, and the Wilson type 80% CI.
Outcome measures
| Measure |
Treatment (Cabozantinib-s-malate)
n=20 Participants
Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
cabozantinib-s-malate: Given PO
fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan
positron emission tomography: Undergo 18F PET/FMAU PET scan
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
PSA Response Based on the RECIST Criteria 1.1
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearSummarized via their frequency distribution, point estimate of the proportion, and the Wilson type 80% CI.
Outcome measures
| Measure |
Treatment (Cabozantinib-s-malate)
n=20 Participants
Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
cabozantinib-s-malate: Given PO
fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan
positron emission tomography: Undergo 18F PET/FMAU PET scan
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
PET Response Based on the RECIST Criteria 1.1
|
19 Participants
|
Adverse Events
Treatment (Cabozantinib-s-malate)
Serious events: 4 serious events
Other events: 20 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Treatment (Cabozantinib-s-malate)
n=20 participants at risk
Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
cabozantinib-s-malate: Given PO
fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan
positron emission tomography: Undergo 18F PET/FMAU PET scan
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Musculoskeletal and connective tissue disorders
hand foot syndrome
|
5.0%
1/20 • Number of events 1 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
General disorders
fatigue
|
5.0%
1/20 • Number of events 1 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Renal and urinary disorders
urinary infection
|
5.0%
1/20 • Number of events 1 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Renal and urinary disorders
elevated creatinine
|
5.0%
1/20 • Number of events 1 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
Other adverse events
| Measure |
Treatment (Cabozantinib-s-malate)
n=20 participants at risk
Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
cabozantinib-s-malate: Given PO
fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan
positron emission tomography: Undergo 18F PET/FMAU PET scan
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
15.0%
3/20 • Number of events 3 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Blood and lymphatic system disorders
decreased ALC
|
10.0%
2/20 • Number of events 2 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Gastrointestinal disorders
GERD
|
10.0%
2/20 • Number of events 2 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Renal and urinary disorders
UTI
|
10.0%
2/20 • Number of events 2 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Psychiatric disorders
anorexia
|
70.0%
14/20 • Number of events 14 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Skin and subcutaneous tissue disorders
blisters
|
10.0%
2/20 • Number of events 2 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
30.0%
6/20 • Number of events 6 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Metabolism and nutrition disorders
chills
|
15.0%
3/20 • Number of events 3 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Gastrointestinal disorders
constipation
|
20.0%
4/20 • Number of events 4 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Gastrointestinal disorders
diarrhea
|
45.0%
9/20 • Number of events 9 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
General disorders
dizziness
|
10.0%
2/20 • Number of events 2 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
General disorders
dry mouth
|
25.0%
5/20 • Number of events 5 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Gastrointestinal disorders
dysgeusia
|
30.0%
6/20 • Number of events 6 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
20.0%
4/20 • Number of events 4 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Blood and lymphatic system disorders
edema
|
25.0%
5/20 • Number of events 5 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
General disorders
fatigue
|
85.0%
17/20 • Number of events 17 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Musculoskeletal and connective tissue disorders
hand/foot
|
15.0%
3/20 • Number of events 3 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Nervous system disorders
headache
|
20.0%
4/20 • Number of events 4 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
General disorders
hoarseness
|
25.0%
5/20 • Number of events 5 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Endocrine disorders
hyperglycemia
|
10.0%
2/20 • Number of events 2 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Vascular disorders
hypertension
|
60.0%
12/20 • Number of events 12 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Blood and lymphatic system disorders
hypophosphatemia
|
10.0%
2/20 • Number of events 2 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Endocrine disorders
hypothyroidism
|
25.0%
5/20 • Number of events 5 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Blood and lymphatic system disorders
increased ALT
|
10.0%
2/20 • Number of events 2 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Blood and lymphatic system disorders
increased AST
|
20.0%
4/20 • Number of events 4 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Gastrointestinal disorders
mucositis
|
30.0%
6/20 • Number of events 6 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Gastrointestinal disorders
nausea
|
50.0%
10/20 • Number of events 10 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Skin and subcutaneous tissue disorders
rash
|
30.0%
6/20 • Number of events 6 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Renal and urinary disorders
urinary frequency
|
15.0%
3/20 • Number of events 3 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Renal and urinary disorders
urinary retention
|
10.0%
2/20 • Number of events 2 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
Gastrointestinal disorders
vomiting
|
20.0%
4/20 • Number of events 4 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
General disorders
weakness
|
15.0%
3/20 • Number of events 3 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
|
General disorders
weight loss
|
20.0%
4/20 • Number of events 4 • All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
|
Additional Information
Dr. Elisabeth Heath
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place