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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01995058
• Other study ID #: XL184-210
• Status: Terminated
• Phase: Phase 2
• First received: November 14, 2013
• Last updated: February 19, 2015
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: Exelixis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Castration Resistant Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• cabozantinib
Tablets taken orally
• abiraterone
Tablets taken orally daily
• prednisone
Tablets taken orally twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Exelixis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability as assessed by adverse events	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.	Up to 18 months	Yes
Other	Pharmacokinetic Pre-dose Plasma Concentrations of both cabozantinib and abiraterone when administered in combination	When administered in combination, both cabozantinib and abiraterone plasma concentrations will be measured prior to dosing on selected visits	Days 1-4, Week 3, Week 5, Week 7, Week 9, Week 17, and Week 41	No
Other	Overall survival	Overall survival is defined as the time from randomization to death from any cause.	Up to 36 months	No
Other	Bone scan response by computer-aided detection (CAD)	Bone scans will be evaluated by an independent radiology facility for response	Up to 18 months	No
Other	Pharmacokinetic Plasma Area Under the Curve (AUC)	For selected subjects, the plasma AUC of cabozantinib and abiraterone will be measured at Week 5	Week 5	No
Primary	Radiographic progression free survival (PFS)	PFS is defined as the time from randomization to the earlier of the following events: disease progression or death due to any cause	Up to 18 months	No