Trial Outcomes & Findings for Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer (NCT NCT01347788)

Results Overview

Bone scans will be centrally reviewed and categorized based on comparison of week 6 and baseline imaging. Partial response is defined as 30% or greater decrease in bone scan lesion area from baseline to week 6. An adaptive response design to determine the lowest effective cabozantinib dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

34 participants

Primary outcome timeframe

Baseline and Week 6

Results posted on

2016-11-28

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 0 Cabozantinib 40 mg daily	Dose Level -1 Cabozantinib 20 mg daily	Expansion Cohort Cabozantinib 40 mg daily
Overall Study STARTED	11	10	13
Overall Study COMPLETED	11	10	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cabozantinib n=34 Participants Final results have been published Clin Cancer Res. 2013 Jun 1;19(11):3088-94. doi: 10.1158/1078-0432.CCR-13-0319. Epub 2013 Apr 3. A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases. Lee RJ, Saylor PJ, Michaelson MD, Rothenberg SM, Smas ME, Miyamoto DT, Gurski CA, Xie W, Maheswaran S, Haber DA, Goldin JG, Smith MR. Author information Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, USA. [email protected]
Age, Continuous	66 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6

Bone scans will be centrally reviewed and categorized based on comparison of week 6 and baseline imaging. Partial response is defined as 30% or greater decrease in bone scan lesion area from baseline to week 6. An adaptive response design to determine the lowest effective cabozantinib dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.

Outcome measures

Outcome measures
Measure	Cohort 1 n=11 Participants Dose level 0: cabozantinib 40 mg daily	Cohort 2 n=10 Participants Dose level -1: cabozantinib 20 mg daily	Expansion Cohort n=13 Participants Dose level 0: cabozantinib 40 mg daily
Partial Response in Bone Scan From Baseline to Week 6	9 participants	1 participants	6 participants

Adverse Events

Cohort 1

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=11 participants at risk Dose level 0: cabozantinib 40 mg daily	Cohort 2 n=10 participants at risk Dose level -1: cabozantinib 20 mg daily	Cohort 3 n=13 participants at risk Dose level 0: cabozantinib 40 mg daily
Vascular disorders venous thromboembolic event	9.1% 1/11 • Number of events 1 • Over the entire study period	0.00% 0/10 • Over the entire study period	7.7% 1/13 • Number of events 1 • Over the entire study period

Other adverse events

Other adverse events
Measure	Cohort 1 n=11 participants at risk Dose level 0: cabozantinib 40 mg daily	Cohort 2 n=10 participants at risk Dose level -1: cabozantinib 20 mg daily	Cohort 3 n=13 participants at risk Dose level 0: cabozantinib 40 mg daily
General disorders weight loss	18.2% 2/11 • Number of events 2 • Over the entire study period	0.00% 0/10 • Over the entire study period	15.4% 2/13 • Number of events 2 • Over the entire study period

Additional Information

Matthew R Smith, MDPhD

Massachusetts General Hospital

Phone: 617-763-3748

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place