Trial Outcomes & Findings for ZD4054 With Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) for Prostate Cancer (NCT NCT01119118)
NCT ID: NCT01119118
Last Updated: 2019-11-21
Results Overview
Multimodal Positron Emission Tomography (PET) and Magnetic Resonant Imaging (MRI) imaging were used to evaluate changes in the tumor lesion size following 6 weeks of treatment with ZD4054.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Week 6
Results posted on
2019-11-21
Participant Flow
Subjects were screened and enrolled at the University of Wisconsin Carbone Cancer Center from April 2010 until July 2011.
Participant milestones
| Measure |
ZD4054
ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
ZD4054
ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
ZD4054 With Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) for Prostate Cancer
Baseline characteristics by cohort
| Measure |
ZD4054
n=6 Participants
ZD4054 + multimodal PET/MRI imaging
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
|
Prior Therapy
Prior Antiandrogen and Cytotoxic Chemotherapy
|
5 Participants
n=5 Participants
|
|
Prior Therapy
Prior Antiandrogen Therapy (no prior chemo)
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6Multimodal Positron Emission Tomography (PET) and Magnetic Resonant Imaging (MRI) imaging were used to evaluate changes in the tumor lesion size following 6 weeks of treatment with ZD4054.
Outcome measures
| Measure |
ZD4054
n=6 Participants
ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
|
|---|---|
|
The Number of Subjects Whose Tumor Lesion Size Changed After 6 Weeks of Treatment With ZD4054 Using PET and MRI Scans.
|
0 participants
|
SECONDARY outcome
Timeframe: Week 6Outcome measures
| Measure |
ZD4054
n=6 Participants
ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
|
|---|---|
|
The Number of Subjects Whose Tumor Lesion Size Changed Using Positron Emission Tomography (PET) Imaging Alone.
|
0 participants
|
SECONDARY outcome
Timeframe: Week 6Outcome measures
| Measure |
ZD4054
n=6 Participants
ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
|
|---|---|
|
The Number of Subjects Whose Tumor Lesion Size Changed Using Diffusion-weighted Imaging (DWI)-Magnetic Resonant Imaging (MRI) Alone
|
0 participants
|
SECONDARY outcome
Timeframe: Week 6Outcome measures
| Measure |
ZD4054
n=6 Participants
ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
|
|---|---|
|
Number of Subjects Whose Tumor Lesion Size Changed Using Iterative Decomposition of Water and Fat With Echo Asymmetry and Least-squares Estimation (IDEAL)-MRI Imaging Alone
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
ZD4054
n=6 Participants
ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
|
|---|---|
|
Number of Subjects With PSA Response
|
0 participants
|
Adverse Events
ZD4054
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZD4054
n=6 participants at risk
ZD4054 + multimodal PET/MRI imaging
|
|---|---|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Gastrointestinal disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • 14 months
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • 14 months
|
Other adverse events
| Measure |
ZD4054
n=6 participants at risk
ZD4054 + multimodal PET/MRI imaging
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
33.3%
2/6 • Number of events 2 • 14 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Cardiac disorders
Cardiac Arrhythmia
|
33.3%
2/6 • Number of events 2 • 14 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
33.3%
2/6 • Number of events 2 • 14 months
|
|
General disorders
Fever
|
50.0%
3/6 • Number of events 3 • 14 months
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Number of events 3 • 14 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 3 • 14 months
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
33.3%
2/6 • Number of events 2 • 14 months
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 3 • 14 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
General disorders
Edema: limb
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Investigations
AST increased
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Investigations
Albumin, serum-low
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Investigations
Calcium, serum-low (hypocalcemia)
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Investigations
Sodium, serum-low (hyponatremia)
|
33.3%
2/6 • Number of events 2 • 14 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Psychiatric disorders
Mood alteration - Depression
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Psychiatric disorders
Neurology - Other
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
33.3%
2/6 • Number of events 4 • 14 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Head/headache
|
33.3%
2/6 • Number of events 2 • 14 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
16.7%
1/6 • Number of events 1 • 14 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
16.7%
1/6 • Number of events 1 • 14 months
|
Additional Information
Dr. Glenn Liu
University of Wisconsin Carbone Cancer Center
Phone: 608-265-8689
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place