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

NCT01995058 | Terminated Phase 2 Results

• 1 other identifier: XL184-210
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

Prostate Cancer; Castration Resistant Prostate Cancer; Prostatic Neoplasms

Keywords

CRPC; castration resistant prostate cancer; prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 18 Months

Study Arms (4)

Arm 1: Cabozantinib 40 mg + abiraterone with prednisone

EXPERIMENTAL

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

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

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

Drug: cabozantinib; Drug: abiraterone; Drug: prednisone

Arm 4: Abiraterone and prednisone only

ACTIVE COMPARATOR

Abiraterone with prednisone

Drug: abiraterone; Drug: prednisone

Interventions

cabozantinib DRUG

Also known as: XL184

Arm 1: Cabozantinib 40 mg + abiraterone with prednisone; Arm 2: Cabozantinib 20 mg + abiraterone and prednisone; Arm 3: Cabozantinib 20 mg (every other day) + abiraterone and prednisone

abiraterone DRUG

Also known as: Zytiga(R), abiraterone acetate

Arm 1: Cabozantinib 40 mg + abiraterone with prednisone; Arm 2: Cabozantinib 20 mg + abiraterone and prednisone; Arm 3: Cabozantinib 20 mg (every other day) + abiraterone and prednisone; Arm 4: Abiraterone and prednisone only

prednisone DRUG

Arm 1: Cabozantinib 40 mg + abiraterone with prednisone; Arm 2: Cabozantinib 20 mg + abiraterone and prednisone; Arm 3: Cabozantinib 20 mg (every other day) + abiraterone and prednisone; Arm 4: Abiraterone and prednisone only

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Exelixis: lead

Study Sites (20)

Unknown Facility

Scottsdale, Arizona, 85258, United States

Location

Unknown Facility

Sedona, Arizona, 86336, United States

Location

Unknown Facility

Tucson, Arizona, 85710, United States

Location

Unknown Facility

Oxnard, California, 93030, United States

Location

Unknown Facility

San Diego, California, 92108, United States

Location

Unknown Facility

Aurora, Colorado, 80012, United States

Location

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Athens, Georgia, 30607, United States

Location

Unknown Facility

Atlanta, Georgia, 30318, United States

Location

Unknown Facility

Peoria, Illinois, 61615, United States

Location

Unknown Facility

Wichita, Kansas, 67214, United States

Location

Unknown Facility

Las Vegas, Nevada, 89148, United States

Location

Unknown Facility

Raleigh, North Carolina, 27607, United States

Location

Unknown Facility

Tualatin, Oregon, 97062, United States

Location

Unknown Facility

Charleston, South Carolina, 29414, United States

Location

Unknown Facility

Greenville, South Carolina, 29605, United States

Location

Unknown Facility

Myrtle Beach, South Carolina, 29572, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

Houston, Texas, 77024, United States

Location

Unknown Facility

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabozantinib; abiraterone; Abiraterone Acetate; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Limitations and Caveats

This study was terminated for business reasons prior to completing enrollment. No efficacy data were collected and limited safety data were collected. No statistical comparisons between treatment arms could be made due to low subject numbers.

Results Point of Contact

• Title: Exelixis Medical Information
• Organization: Exelixis, Inc.

druginfo@exelixis.com

855-292-3935

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 26, 2013
• Study Start: February 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-12

Locations

US (20)