Clinical trial NCT01995058: Study of Cabozantinib in Combination With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Castration Resistant Prostate Cancer
Prostatic Neoplasms
Keywords: CRPC
castration resistant prostate cancer
prostate cancer
Lead sponsor: Exelixis
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


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

Primary outcomes:
measure: Radiographic progression free survival (PFS)
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
measure: Safety and tolerability as assessed by adverse events
timeFrame: Up to 18 months
measure: Pharmacokinetic Pre-dose Plasma Concentrations of both cabozantinib and abiraterone when administered in combination
timeFrame: Days 1-4, Week 3, Week 5, Week 7, Week 9, Week 17, and Week 41
measure: Overall survival
timeFrame: Up to 36 months
measure: Bone scan response by computer-aided detection (CAD)
timeFrame: Up to 18 months
measure: Pharmacokinetic Plasma Area Under the Curve (AUC)
timeFrame: Week 5
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Sedona
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Oxnard
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Aurora
country: United States
state: Colorado
city: Athens
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Peoria
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Las Vegas
country: United States
state: Nevada
city: Raleigh
country: United States
state: North Carolina
city: Tualatin
country: United States
state: Oregon
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
References: