Trial Outcomes & Findings for Tivozanib + Enzalutamide in Adv Prostate Cancer (NCT NCT01885949)

NCT ID: NCT01885949

Last Updated: 2025-07-16

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: 2025-07-16

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=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

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.

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 years

Population: 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	0 events

SECONDARY outcome

Timeframe: 2 years

Population: 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 years

Population: 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 years

Population: 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: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dror Michaelson

MGH Cancer Center

Phone: 6177244000

Email: dmichaelson1@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place