Prostate CancerPhase 2NCT01995058

Combo of Cabozantinib With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic CRPC

A Phase 2 study testing cabozantinib, abiraterone and prednisone in people with Prostate Cancer and Castration Resistant Prostate Cancer, run by Exelixis at 20 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study was conducted in subjects in chemotherapy-naïve subjects with bone-metastatic castration-resistant prostate cancer (CRPC). Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer, Castration Resistant Prostate Cancer, Prostatic Neoplasms
What is being tested?: cabozantinib, abiraterone and prednisone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 20 sitesUnited States
Study dates: Feb 2014to Nov 2014
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed adenocarcinoma of the prostate.
Must be surgically or medically castrated (serum testosterone levels less than or equal to 50 ng/dL)
Must have castration-resistant prostate cancer (CRPC) with disease progression during LHRH therapy or after a surgical bilateral orchiectomy.
Bone metastasis related to prostate cancer
Adequate organ and marrow function
Capable of understanding and complying with the protocol requirements and signed the informed consent document
Sexually active subjects and their partners must agree to use medically accepted methods of barrier contraception (eg, male condom or female condom) as well as one other medically accepted method of contraception during the course of the study treatment and for 4 months after the last dose of study treatment.

Who cannot join

Any prior treatment with abiraterone, enzalutamide, or any investigational agents blocking androgen receptor (AR) or androgen synthesis.
Any prior treatment with cabozantinib or participation in a prior clinical trial of cabozantinib.
Any prior cytotoxic therapy (including estramustine) or biologic therapy for the treatment of prostate cancer (a few exceptions will be allowed)
Any prior radionuclide therapy (eg, samarium 153, strontium 89, alpharadin)
Use of investigational agent within 28 days
Any pathological finding consistent with small cell carcinoma of the prostate
Known brain metastases or cranial epidural disease
Diagnosis of another malignancy within 2 years, except for superficial non-melanoma skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Athens, Georgia, 30607
Study site
Atlanta, Georgia, 30318
Study site
Aurora, Colorado, 80012
Study site
Aurora, Colorado, 80045
Study site
Charleston, South Carolina, 29414
Study site
Dallas, Texas, 75246
Study site
Greenville, South Carolina, 29605
Study site
Houston, Texas, 77024
Study site
Las Vegas, Nevada, 89148
Study site
Myrtle Beach, South Carolina, 29572
Study site
Oxnard, California, 93030
Study site
Peoria, Illinois, 61615
Study site
Raleigh, North Carolina, 27607
Study site
Salt Lake City, Utah, 84112
Study site
San Diego, California, 92108
Study site
Scottsdale, Arizona, 85258
Study site
Sedona, Arizona, 86336
Study site
Tualatin, Oregon, 97062
Study site
Tucson, Arizona, 85710
Study site
Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: A Randomized Phase 2 Study of Cabozantinib (XL184) in Combination With Abiraterone in Chemotherapy Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer (CRPC)

This study was conducted in subjects in chemotherapy-naïve subjects with bone-metastatic castration-resistant prostate cancer (CRPC).

Read the detailed description

The goal of this clinical trial was to learn if the combination of the drugs cabozantinib and abiraterone works for men that were chemotherapy-naive, bone metastasis CRPC patients. It was designed to learn about the safety of cabozantinib. The main questions are:

Does it work and is it safe in men with chemotherapy-naïve bone- metastatic castration resistant CRPC?
What was the clinical benefit at different dose levels of the combination of abiraterone and cabozantinib in this patient population?

Participants were assigned to one of the four treatment groups:

Arm 1. cabozantinib at a dose of 40 mg every day (QD) plus abiraterone with prednisone; Arm 2. cabozantinib at a dose of 20 mg QD plus abiraterone with prednisone; Arm 3. cabozantinib at a dose of 20 mg every other day (QOD) plus abiraterone with prednisone; Arm 4. abiraterone with prednisone.

Conditions: Prostate Cancer, Castration Resistant Prostate Cancer, Prostatic Neoplasms
Being tested: cabozantinib, abiraterone, prednisone
Keywords: CRPC, castration resistant prostate cancer, prostate cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cabozantinibDrug
Also called XL184
abirateroneDrug
Also called Zytiga(R), abiraterone acetate
prednisoneDrug

Study groups in NCT01995058
Study group	Role	What they receive
Arm 1: Cabozantinib 40 mg + abiraterone with prednisone	Experimental	Cabozantinib 40 mg, by mouth daily (po QD), + abiraterone with prednisone Receives: Drug: cabozantinib; Drug: abiraterone; Drug: prednisone
Arm 2: Cabozantinib 20 mg + abiraterone and prednisone	Experimental	Cabozantinib 20 mg, by mouth daily (po QD), + abiraterone with prednisone Receives: Drug: cabozantinib; Drug: abiraterone; Drug: prednisone
Arm 3: Cabozantinib 20 mg (every other day) + abiraterone and prednisone	Experimental	Cabozantinib 20 mg every other day with abiraterone and prednisone Receives: Drug: cabozantinib; Drug: abiraterone; Drug: prednisone
Arm 4: Abiraterone and prednisone only	Active comparator	Abiraterone with prednisone Receives: Drug: abiraterone; Drug: prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiographic Progression Free Survival (PFS)
PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause, as assessed by Independent Radiology Committee (IRC). The sponsor terminated the study early due to business reasons. As such, no data were collected for efficacy analyses.
Measured: Up to 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Nov 2014

First posted26 Nov 2013 (estimated)
Study startFeb 2014
Primary completionNov 2014
Study completionNov 2014

Why it stopped: Sponsor decided to close the study prior to completion of enrollment. This was a business decision and not based on the safety results of the study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by ExelixisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01995058
Sponsor's protocol ID: XL184-210
Status last verified: Dec 2025
First submitted: 14 Nov 2013
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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