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Clinical Trial Results:
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100 (COMET-1)

Summary
EudraCT number	2012-001834-33
Trial protocol	BE DE NL SE AT IE ES IT GB
Global end of trial date	25 Feb 2015

Results information
Results version number	v1(current)
This version publication date	22 Jan 2021
First version publication date	22 Jan 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
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Trial information

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Sponsor protocol code

XL184–307

ISRCTN number

US NCT number

NCT01605227

WHO universal trial number (UTN)

Sponsor organisation name

Exelixis

Sponsor organisation address

1851 Harbor Bay Pkwy, Alameda, United States, 94502

Public contact

Exelixis Medical Affairs, Exelixis, Inc., 1 8883935494,

Scientific contact

Exelixis Medical Affairs, Exelixis, Inc., 1 8883935494,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

07 Jul 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

07 Jul 2014

Global end of trial reached?

Yes

Global end of trial date

25 Feb 2015

Was the trial ended prematurely?

Yes

Main objective of the trial

The objective of this study is to evaluate the effect of cabozantinib compared to prednisone on overall survival (OS) in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100 (enzalutamide).

Protection of trial subjects

The safety information from this study was reviewed by the Independent Data Monitoring Committee (IDMC) on a regular basis. An Exelixis internal Safety Committee met quarterly to review safety data.

Background therapy

Evidence for comparator

The rationale for the use of prednisone over placebo was to offer participating subjects an active comparator which may serve to relieve pain associated with bone metastases and prolong participation in this study. While studies with a primary endpoint of OS do not necessarily require blinding of study treatment, the use of a double-blind design, despite differential toxicity profiles between treatments, may minimize investigator bias that could affect the determination of progression and study therapy discontinuation. For this reason, prednisone plus a cabozantinib-matched placebo was chosen as the comparator regimen in this study. Subjects who received active cabozantinib also received placebo prednisone to preserve blinding. The protocol allowed prednisolone to be supplied as study treatment instead of prednisone in some countries or regions; however, only prednisone was used in this study.

Actual start date of recruitment

02 Jul 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country