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An Abiraterone Acetate Plus Prednisone Drug-Drug Interaction Study With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Neoplasms

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Trial Information

An Abiraterone Acetate Plus Prednisone Drug-Drug Interaction Study With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer


This is an open-label (identity of assigned study drug will be known) study of abiraterone
acetate plus prednisone in male patients with metastatic castration-resistant prostate
cancer. This study will consist of screening, treatment, and follow-up periods, and will
have 2 study groups. Patients in Group A and B will receive daily abiraterone acetate (1000
mg) plus prednisone (5 mg) twice daily beginning on Cycle 1 Day 1 until disease progression.
Patients in Group A will take dextromethorphan hydrobromide 30 mg administered orally once
daily on Day -8 and Day 8 of Cycle 1. Patients in Group B will take theophylline 100 mg
administered orally once daily on Day -8 and Day 8 of Cycle 1. Serial pharmacokinetic
samples will be collected and safety will be monitored throughout the study.


Inclusion Criteria:



- Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell histology

- Documented metastatic disease

- Documented prostate specific antigen (PSA) progression according to Prostate Cancer
Working Group 2 criteria, with PSA value >=2 ng/mL despite medical or surgical
castration, or prostate cancer progression documented by radiographic progression
according to Response Evaluation Criteria In Solid Tumors criteria

- Surgically or medically castrated with testosterone levels of <50 ng/dL

- Eastern Cooperative Oncology Group (ECOG) Performance Status of <=2

- Group A only: genomic testing at screening indicating CYP2D6 extensive metabolizer
status

- Protocol-defined laboratory values

Exclusion Criteria:

- Serious or uncontrolled co-existent non-malignant disease, including active and
uncontrolled infection

- Group A only: genomic testing at screening indicating CYP2D6 non-extensive
metabolizer status, or prior treatment with dextromethorphan-containing medication or
any medication that is a strong inhibitor or inducer of CYP2D6 within 5 half-lives of
that drug or 7 days, whichever is longer, prior to Cycle 1 Day -8

- Group B only: prior treatment with theophylline or any medication that is a strong
inhibitor or inducer of CYP1A2 within 5 half-lives of that drug or 7 days, whichever
is longer, prior to Cycle 1 Day -8

- Abnormal liver function

- Uncontrolled hypertension (repeated systolic blood pressure >=160 mmHg, or diastolic
blood pressure >=95 mmHg)

- Active or symptomatic viral hepatitis or chronic liver disease

- Known brain metastasis

- History of pituitary or adrenal dysfunction

- Clinically significant heart disease as evidenced by myocardial infarction, or
arterial thrombotic events in the past 6 months, severe or unstable angina, or New
York Heart Association Class III or IV heart disease or cardiac ejection fraction
measurement of <50% at baseline

- History of gastrointestinal disorders (medical disorders or extensive surgery) which
may interfere with the absorption of the study drug

- Surgery or local prostatic intervention within 28 days of the first dose, and any
clinically relevant sequelae from the surgery must have resolved prior to Cycle 1 Day
1

- Radiotherapy or immunotherapy within 28 days, or single fraction of palliative
radiotherapy within 14 days of administration of Cycle 1 Day 1

- Any acute toxicities due to prior therapy that have not resolved

- Current enrollment in an investigational drug or device study or participation in
such a study within 28 days of Cycle 1 Day 1

- Previous abiraterone acetate or other investigational CYP17 inhibitor (eg, TAK-700)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ratio of the mean area under the concentration curve (AUC) of dextromethorphan, dextrorphan, and parent/metabolite, with and without co-administration of abiraterone acetate and prednisone

Outcome Time Frame:

Cycle 1 Day -8 and Day 8

Safety Issue:

No

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC

Authority:

United States: Food and Drug Administration

Study ID:

CR017128

NCT ID:

NCT01017939

Start Date:

January 2010

Completion Date:

April 2012

Related Keywords:

  • Prostate Neoplasms
  • Prostate neoplasms
  • Metastatic castration resistant prostate cancer
  • Metastatic castration refractory prostate cancer
  • Prostate cancer
  • Abiraterone acetate
  • CB7630
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Fountain Valley, California  92708
Austin, Texas  78705
Tower Cancer Research FoundationBeverly Hills, California  90211
START - South Texas Accelerated Research Therapeutics, LLCSan Antonio, Texas  78229