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Study of Cabozantinib in Combination With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01995058
First received: November 14, 2013
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

This study is designed to evaluate the safety and efficacy of combining abiraterone (with prednisone) with cabozantinib in chemotherapy-naïve subjects with bone-metastatic castration-resistant prostate cancer (CRPC).


Condition Intervention Phase
Prostate Cancer
Castration Resistant Prostate Cancer
Prostatic Neoplasms
Drug: cabozantinib
Drug: abiraterone
Drug: prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Exelixis:

Primary Outcome Measures:
  • Radiographic progression free survival (PFS) [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to the earlier of the following events: disease progression or death due to any cause


Other Outcome Measures:
  • Safety and tolerability as assessed by adverse events [ Time Frame: Up to 18 months ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    When administered in combination, both cabozantinib and abiraterone plasma concentrations will be measured prior to dosing on selected visits

  • Overall survival [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from randomization to death from any cause.

  • Bone scan response by computer-aided detection (CAD) [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    Bone scans will be evaluated by an independent radiology facility for response

  • Pharmacokinetic Plasma Area Under the Curve (AUC) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    For selected subjects, the plasma AUC of cabozantinib and abiraterone will be measured at Week 5


Estimated Enrollment: 280
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabozantinib arm 1
Subjects randomized to this arm will receive cabozantinb 40 mg daily with abiratarone and prednisone
Drug: cabozantinib
Tablets taken orally
Other Name: XL184
Drug: abiraterone
Tablets taken orally daily
Other Names:
  • Zytiga(R)
  • abiraterone acetate
Drug: prednisone
Tablets taken orally twice daily
Experimental: Cabozantinib arm 2
Subjects randomized to this arm will receive cabozantinib 20 mg daily with abiraterone and prednisone
Drug: cabozantinib
Tablets taken orally
Other Name: XL184
Drug: abiraterone
Tablets taken orally daily
Other Names:
  • Zytiga(R)
  • abiraterone acetate
Drug: prednisone
Tablets taken orally twice daily
Experimental: Cabozantinib arm 3
Subjects randomized to this arm will receive cabozantinb 20 mg every other day with abiraterone and prednisone
Drug: cabozantinib
Tablets taken orally
Other Name: XL184
Drug: abiraterone
Tablets taken orally daily
Other Names:
  • Zytiga(R)
  • abiraterone acetate
Drug: prednisone
Tablets taken orally twice daily
Active Comparator: Abiraterone only arm (4)
Subjects randomized to this arm will receive abiraterone with prednisone only
Drug: abiraterone
Tablets taken orally daily
Other Names:
  • Zytiga(R)
  • abiraterone acetate
Drug: prednisone
Tablets taken orally twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995058

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

No publications provided

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01995058     History of Changes
Other Study ID Numbers: XL184-210
Study First Received: November 14, 2013
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Exelixis:
CRPC
castration resistant prostate cancer
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014