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

NCT ID: NCT01995058

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-11-30

Brief 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.

Conditions

Prostate Cancer; Castration Resistant Prostate Cancer; Prostatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Cabozantinib 40 mg + abiraterone with prednisone

Cabozantinib 40 mg, by mouth daily (po QD), + abiraterone with prednisone

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

abiraterone

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

Arm 2: Cabozantinib 20 mg + abiraterone and prednisone

Cabozantinib 20 mg, by mouth daily (po QD), + abiraterone with prednisone

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

abiraterone

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

Arm 3: Cabozantinib 20 mg (every other day) + abiraterone and prednisone

Cabozantinib 20 mg every other day with abiraterone and prednisone

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

abiraterone

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

Arm 4: Abiraterone and prednisone only

Abiraterone with prednisone

Group Type: ACTIVE_COMPARATOR

abiraterone

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

Interventions

cabozantinib

Intervention Type: DRUG

abiraterone

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

Other Intervention Names

XL184; Zytiga(R); abiraterone acetate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Exelixis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Aurora, Colorado, United States

Athens, Georgia, United States

Atlanta, Georgia, United States

Peoria, Illinois, United States

Wichita, Kansas, United States

Las Vegas, Nevada, United States

Raleigh, North Carolina, United States

Tualatin, Oregon, United States

Charleston, South Carolina, United States

Greenville, South Carolina, United States

Myrtle Beach, South Carolina, United States

Dallas, Texas, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

XL184-210

Identifier Type: -

Identifier Source: org_study_id