An Observational Study of Continuous Oral Dosing of Abiraterone Acetate in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma

NCT00544440 | Completed Phase 2 Results DMC

• 2 other identifiers: CR016906COU-AA-BMA
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of abiraterone acetate on levels of androgens and steroid metabolites in bone marrow plasma of patients with metastatic castration-resistant prostate cancer (CRPC).

Conditions

Prostate Neoplasms

Keywords

Prostate neoplasms; Prostate cancer; Castration-resistant prostate cancer; Abiraterone acetate; CB7630; Prednisone; Testosterone; Bone marrow

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)

  Baseline (predose Week 1 Day 1) and Week 8

• Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)

  Baseline (predose Week 1 Day 1) and Week 8

• Difference in Bone Marrow Testosterone Levels Between Participants With and Without Serum Prostate Specific Antigen Decline

  Week 8

Secondary Outcomes (1)

• Number of Participants With Change in Markers of Bone Metabolism

  Week 8

Study Arms (1)

Abiraterone acetate plus prednisone

EXPERIMENTAL

Patients will be treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.

Drug: Abiraterone acetate; Drug: Prednisone

Interventions

Abiraterone acetate DRUG

Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily

Abiraterone acetate plus prednisone

Prednisone DRUG

Prednisone 5 mg tablet taken orally twice daily

Abiraterone acetate plus prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven adenocarcinoma of the prostate
• Eastern Cooperative Oncology Group (ECOG) performance status \<=2 (Karnofsky Performance Status \>=50%)
• Serum testosterone levels \<50ng/ml
• Ongoing gonadal androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) analogues or orchiectomy (patients, who have not had an orchiectomy, must be maintained on effective LHRH analogue therapy for the duration of the study)
• Progression of disease despite androgen ablation (either documented osseous or soft tissue metastatic disease progression or by prostate specific antigen \[PSA\] criteria progression)
• Progressive disease is defined by PSA evidence (PSA level of at least 5 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart)
• Presence of metastatic bone disease
• Discontinue diethylstilbestrol or steroids treatment for \>=4 weeks and for antiandrogens \>6 weeks
• Antiandrogen withdrawal: patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen (disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression)
• For patients receiving flutamide, at least one of the PSA values must be obtained 4 weeks or more after flutamide discontinuation
• For patients receiving bicalutamide or nilutamide, at least one of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation
• Adequate adrenal function
• Laboratory values within protocol -defined parameters
• No evidence of chronic or acute disseminated intravascular coagulation or bleeding tendency and no angina at rest
• Agrees to protocol-defined use of effective contraception

You may not qualify if:

• Histologic variants other than adenocarcinoma in the primary tumor
• More then 2 different prior chemotherapeutic regimens for metastatic prostate cancer
• Abnormal liver function
• Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), Ketoconazole, finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (eg, Saw Palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks prior to first dose of study drug
• Active infection or intercurrent illness that are not controlled
• Unstable angina, myocardial infarction within the previous 6 months, or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia, uncontrolled hypertension, New York Heart Association (NYHA) Class III or IV congestive heart failure
• Prior radiation therapy completed \<4 weeks or single fraction of palliative radiotherapy within 14 days prior to first dose of study drug
• Any currently active second malignancy, other than non-melanoma skin cancer
• Active psychiatric illnesses/social situations that would limit compliance with protocol requirements
• Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study
• Severely compromised immunological state, including being positive for the human immunodeficiency virus (HIV)
• Acute or chronic hepatitis B or C
• Initiation of bisphosphonate therapy within 4 weeks prior to first dose of study drug
• Long QT syndrome or bundle branch block or hemiblock or other history of life-threatening arrhythmia (unless the patient has been effectively treated for it and is considered stable)
• Known brain metastasis

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Houston, Texas, United States

Location

Related Links

• NATIONAL CANCER INSTITUTE
• NATIONAL INSTITUTE OF HEALTH

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Senior Director
• Organization: Clinical Research, Janssen R&D, 10990 Wilshire Blvd, Suite 1200, Los Angeles, CA 90024

310-943-8040

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 16, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 17, 2014
• Results First Posted: November 1, 2013

Record last verified: 2014-07

Locations

US (1)