A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients
NCT01650194
ABOUT THIS STUDY
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- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- Presence of metastatic disease to the bone
- Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration)
- Subject receiving bisphosphonate or denosumab therapy must have been on stable doses for at least 4 weeks prior to Day 1
- Progressive disease defined as one or more of the following three criteria (Note: subjects who received an antiandrogen must demonstrate disease progression following discontinuation of antiandrogen):
- PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the Screening visit should be ≥ 2 ng/mL
- Soft tissue disease progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Bone disease progression defined by PCWG2 criteria (two or more new lesions on bone scan compared with prior scan)
- Subject previously treated with chemotherapy must have no more than two prior chemotherapy regimens for the treatment of metastatic prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Agree to use a double-barrier method of contraception which involves the use of a condom in combination with one of the following: contraceptive sponge, diaphragm, or cervical ring with spermicidal gel or foam, if having sex with a woman of child-bearing potential during the length of the study and for one week after abiraterone is discontinued and for at least three months after enzalutamide is discontinued
- Subject agrees not to participate in another interventional study while on treatment
- Known or suspected metastases in the brain
- Absolute neutrophil count < 1,000/μL, platelet count < 75,000/μL, and hemoglobin < 9
g/dL (NOTE: subject may not have received any growth factors or blood transfusions
within seven days of the hematologic laboratory values obtained at the Screening
visit)
- Total bilirubin (TBL), alanine aminotransferase (ALT) or aspartate aminotransferase
(AST) > 2.5 times the upper limit of normal
- Creatinine (Cr) > 2 mg/dL
- Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide),
5-α reductase inhibitors (finasteride, dutasteride), estrogens, chemotherapy, or
biologic therapy within 4 weeks of Day 1 visit
- Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks)
of Day 1 visit, or radionuclide therapy within 8 weeks of Day 1
- Planned palliative procedures for alleviation of bone pain such as radiation therapy
or surgery
- Structurally unstable bone lesions suggesting impending fracture
- History of seizure or any condition that may predispose to seizure including, but not
limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or
alcoholism. Also, history of loss of consciousness or transient ischemic attack within
12 months of enrollment (Day 1 visit)
- Clinically significant cardiovascular disease including:
- Myocardial infarction within 6 months of Screening visit;
- Uncontrolled angina within 3 months of Screening visit;
- Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or
subjects with history of congestive heart failure NYHA class 3 or 4 in the past,
or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a
screening echocardiogram or multi-gated acquisition scan (MUGA) performed within
three months of the Screening visit results in a left ventricular ejection
fraction that is ≥ 45%
- History of clinically significant ventricular arrhythmias (e.g., ventricular
tachycardia, ventricular fibrillation, torsade de pointes)
- Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on
the Electrocardiogram (ECG) > 470 msec.
- History of Mobitz II second degree or third degree heart block without a
permanent pacemaker in place
- Hypotension (systolic blood pressure < 86 mmHg or bradycardia with a heart rate
of <50 beats per minute on the ECG., unless pharmaceutically induced and thus
reversible (i.e. beta blockers).
- Uncontrolled hypertension as indicated by a resting systolic blood pressure >170
mmHg or diastolic blood pressure >105 mmHg
- Prior use of ketoconazole, abiraterone acetate or enzalutamide, or participation in a
previous clinical trial of ketoconazole, abiraterone acetate or enzalutamide
- History of significant bleeding disorder unrelated to cancer, including:
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor
VIII antibodies) of Screening visit
- History of GI bleeding within 6 months of Screening visit
- Active or symptomatic viral hepatitis or chronic liver disease
- Known history of pituitary or adrenal dysfunction
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Descriptive Information | |||||||||||||||||
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Brief Title ICMJE | A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients | ||||||||||||||||
Official Title ICMJE | A Phase 2 Study Determining Safety and Tolerability of Enzalutamide (Formerly MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients | ||||||||||||||||
Brief Summary | The purpose of this study was to explore the safety and tolerability of enzalutamide in combination with abiraterone acetate plus prednisone. Subjects diagnosed with cancer of the prostate that was getting worse and spreading to the bone despite receiving hormone treatment were enrolled and received study treatment until disease progression. | ||||||||||||||||
Detailed Description | For the study duration, all subjects maintained androgen deprivation with a gonadotropin releasing hormone (GnRH) agonist or antagonist or orchiectomy. Study drug was administered until disease progression. Disease progression was defined as a composite endpoint consisting of either clinical deterioration, radiographic progression or prostate-specific antigen (PSA) progression according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria. | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||||||||||
Condition ICMJE | Metastatic Castration-Resistant Prostate Cancer | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Enzalutamide + Abiraterone + Prednisone
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily. Interventions:
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Publications * | Assi R, Temraz S, Shamseddine A, Mukherji D. New Compounds Targeting the Androgen Receptor for Treatment of Advanced Prostate Cancer. Curr Drug Targets. 2016;17(3):290-302. Review. | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||||||
Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||
Actual Enrollment ICMJE | 60 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Actual Study Completion Date ICMJE | January 4, 2018 | ||||||||||||||||
Actual Primary Completion Date | January 4, 2018 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT01650194 | ||||||||||||||||
Other Study ID Numbers ICMJE | 9785-CL-0011 | ||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ) | ||||||||||||||||
Study Sponsor ICMJE | Astellas Pharma Global Development, Inc. | ||||||||||||||||
Collaborators ICMJE | Medivation LLC, a wholly owned subsidiary of Pfizer Inc. | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Astellas Pharma Inc | ||||||||||||||||
Verification Date | January 2019 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |