Trial Outcomes & Findings for Tivozanib + Enzalutamide in Adv Prostate Cancer (NCT NCT01885949)
NCT ID: NCT01885949
Last Updated: 2026-05-20
Results Overview
The primary objective of this study will be to demonstrate an improvement in progression free survival in men with metastatic castration resistant prostate cancer (mCRPC) treated with tivozanib and enzalutamide.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
2 years
Results posted on
2026-05-20
Participant Flow
Participant milestones
| Measure |
Experimental Treatment Arm
Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days
Tivozanib: Oral
Enzalutamide: oral
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tivozanib + Enzalutamide in Adv Prostate Cancer
Baseline characteristics by cohort
| Measure |
Experimental Treatment Arm
n=5 Participants
Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days
Tivozanib: Oral
Enzalutamide: oral
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe primary objective of this study will be to demonstrate an improvement in progression free survival in men with metastatic castration resistant prostate cancer (mCRPC) treated with tivozanib and enzalutamide.
Outcome measures
| Measure |
Experimental Treatment Arm
n=5 Participants
Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days
Tivozanib: Oral
Enzalutamide: oral
|
|---|---|
|
Progression Free Survival
|
5 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: No Grade 3/4 SAEs
Safety and tolerability of tivozanib and enzalutamide will be assessed. The number of patients having grades 1-4 adverse events by NCI CTC version 4.0 will be recorded.
Outcome measures
| Measure |
Experimental Treatment Arm
n=5 Participants
Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days
Tivozanib: Oral
Enzalutamide: oral
|
|---|---|
|
Safety and Tolerability
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Insufficient patients enrolled to allow statistical analysis of overall survival
To estimate overall survival in patients treated with tivozanib and enzalutamide
Outcome measures
| Measure |
Experimental Treatment Arm
n=5 Participants
Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days
Tivozanib: Oral
Enzalutamide: oral
|
|---|---|
|
Overall Survival
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Insufficient number of patients to allow statistical analysis of data
To evaluate PSA response rate
Outcome measures
| Measure |
Experimental Treatment Arm
n=5 Participants
Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days
Tivozanib: Oral
Enzalutamide: oral
|
|---|---|
|
PSA Response Rate
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Insufficient number of patients to allow statistical analysis of data
The time to PSA progression (in months) will be evaluated in patients treated with enzalutamide and tivozanib
Outcome measures
| Measure |
Experimental Treatment Arm
n=5 Participants
Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days
Tivozanib: Oral
Enzalutamide: oral
|
|---|---|
|
Time to PSA Progression
|
12 months
Standard Deviation 6
|
Adverse Events
Experimental Treatment Arm
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Treatment Arm
n=5 participants at risk
Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days
Tivozanib: Oral
Enzalutamide: oral
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
20.0%
1/5 • 2 years
|
|
Cardiac disorders
Palpitations
|
40.0%
2/5 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
1/5 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • 2 years
|
|
Gastrointestinal disorders
Stomach pain
|
20.0%
1/5 • 2 years
|
|
General disorders and administration site conditions
Edema limbs
|
40.0%
2/5 • 2 years
|
|
General disorders and administration site conditions
Fatigue
|
60.0%
3/5 • 2 years
|
|
General disorders and administration site conditions
Pain
|
40.0%
2/5 • 2 years
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other, specify
|
20.0%
1/5 • 2 years
|
|
Infections and infestations
Papulopustular rash
|
20.0%
1/5 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
1/5 • 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
20.0%
1/5 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
20.0%
1/5 • 2 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
20.0%
1/5 • 2 years
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • 2 years
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • 2 years
|
|
Investigations
Weight loss
|
20.0%
1/5 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
3/5 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
40.0%
2/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • 2 years
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • 2 years
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • 2 years
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • 2 years
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • 2 years
|
|
Reproductive system and breast disorders
Genital edema
|
20.0%
1/5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
20.0%
1/5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
2/5 • 2 years
|
|
Vascular disorders
Hematoma
|
20.0%
1/5 • 2 years
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5 • 2 years
|
|
Vascular disorders
Hypertension
|
80.0%
4/5 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place