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

December 19, 2025 updated by: Exelixis

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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:

  1. Does it work and is it safe in men with chemotherapy-naïve bone- metastatic castration resistant CRPC?
  2. 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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Cabozantinib 40 mg + abiraterone with prednisone
Cabozantinib 40 mg, by mouth daily (po QD), + abiraterone with prednisone
Drug: prednisone
Drug: abiraterone
Other Names:
  • abiraterone acetate
  • Zytiga(R)
Drug: cabozantinib
Other Names:
  • XL184
Experimental: Arm 2: Cabozantinib 20 mg + abiraterone and prednisone
Cabozantinib 20 mg, by mouth daily (po QD), + abiraterone with prednisone
Drug: prednisone
Drug: abiraterone
Other Names:
  • abiraterone acetate
  • Zytiga(R)
Drug: cabozantinib
Other Names:
  • XL184
Experimental: Arm 3: Cabozantinib 20 mg (every other day) + abiraterone and prednisone
Cabozantinib 20 mg every other day with abiraterone and prednisone
Drug: prednisone
Drug: abiraterone
Other Names:
  • abiraterone acetate
  • Zytiga(R)
Drug: cabozantinib
Other Names:
  • XL184
Active Comparator: Arm 4: Abiraterone and prednisone only
Abiraterone with prednisone
Drug: prednisone
Drug: abiraterone
Other Names:
  • abiraterone acetate
  • Zytiga(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Progression Free Survival (PFS)
Time Frame: Up to 18 Months
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.
Up to 18 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability as assessed by adverse events
Time Frame: Up to 18 months
Subjects are followed for safety as assessed by adverse events at least through 30 days after the date of a decision to permanently discontinue study treatment.
Up to 18 months
Pharmacokinetic Pre-dose Plasma Concentrations of both cabozantinib and abiraterone when administered in combination
Time Frame: Days 1-4, Week 3, Week 5, Week 7, Week 9, Week 17, and Week 41
When administered in combination, both cabozantinib and abiraterone plasma concentrations will be measured prior to dosing on selected visits
Days 1-4, Week 3, Week 5, Week 7, Week 9, Week 17, and Week 41
Overall survival
Time Frame: Up to 36 months
Overall survival is defined as the time from randomization to death from any cause.
Up to 36 months
Bone scan response by computer-aided detection (CAD)
Time Frame: Up to 18 months
Bone scans will be evaluated by an independent radiology facility for response
Up to 18 months
Pharmacokinetic Plasma Area Under the Curve (AUC)
Time Frame: Week 5
For selected subjects, the plasma AUC of cabozantinib and abiraterone will be measured at Week 5
Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimated)

November 26, 2013

Study Record Updates

Last Update Posted (Estimated)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL184-210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostatic Neoplasms

Clinical Trials on prednisone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe