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Combo of Cabozantinib With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic CRPC | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT01995058•Exelixis

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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

Locations (20)

Scottsdale, Arizona, United States

Sedona, Arizona, United States

Tucson, Arizona, United States

Oxnard, California, United States

San Diego, California, United States

Aurora, Colorado, United States

Athens, Georgia, United States

Atlanta, Georgia, United States

Peoria, Illinois, United States

Key Dates

Start Date

February 1, 2014

Primary Completion Date

November 1, 2014

Completion Date

November 1, 2014

Last Updated

January 8, 2026

Enrollment

ACTUAL participants

Conditions

Prostate CancerCastration Resistant Prostate CancerProstatic Neoplasms

Interventions

cabozantinib

DRUG

abiraterone

DRUG

prednisone

DRUG

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Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

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Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC