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Prostate NeoplasmsPhase 1NCT00910754

A QT/QTc and Multi-Dose Pharmacokinetic Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 1 study testing Abiraterone acetate and Prednisone in people with Prostate Neoplasms, run by Janssen Research & Development, LLC at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effect of abiraterone acetate plus prednisone on the conduction of electric charges within the heart and to determine the blood levels of abiraterone acetate following administration in patients with metastatic castration-resistant prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Neoplasms
What is being tested?
Abiraterone acetate and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
8 sitesin 2 countries
Study dates
May 2009to May 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Documented metastatic disease
  • Has not received chemotherapy or has no more than one line of cytotoxic chemotherapy or biologic therapy for treatment of castration resistant prostate cancer (CRPC)
  • Documented prostate specific antigen (PSA) progression as assessed by the investigator according to Prostate Cancer Working Group 2 (PCWG2) criteria despite medical or surgical castration, or prostate cancer progression documented by radiographic progression according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria
  • Surgically or medically castrated with testosterone levels of <50 ng/dL (<2.0 nM)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1
  • Agrees to protocol-defined use of effective contraception
  • Protocol-specified laboratory parameters

Who cannot join

  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Abnormal liver function
  • Uncontrolled hypertension
  • Active or symptomatic viral hepatitis or chronic liver disease
  • Known brain metastasis
  • History of pituitary or adrenal dysfunction
Show all 23Show fewer
  • 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 (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
  • Diagnosis of cardiac arrhythmia
  • Treatment with anti-arrhythmic drugs primarily for cardiac arrhythmia
  • Abnormal electrocardiogram
  • Other malignancy (except non-melanoma skin cancer, that is active or has a ≥ 30% probability of recurrence within 24 months) 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 30 days of the first dose
  • Radiotherapy or immunotherapy within 30 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 to a NCI CTCAE (version 3.0) grade of <=1
  • More than one prior cytotoxic chemotherapy or biologic therapy for treatment of CRPC
  • Prior chemotherapy with mitoxantrone or other anthracyclines (ie, doxorubicin, daunomycin, epirubicin and idarubicin)
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1
  • Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1 Day 1
  • Prior bicalutamide (Casodex), nilutamide (Nilandron, Anandron) within 6 weeks of Cycle 1 Day 1
  • Previous abiraterone acetate or other investigational CYP17 inhibitor (eg, TAK-700)
  • Previous investigational antiandrogens (eg, MDV3100, BMS-641988)
  • Patients receiving anti-coagulant therapy
  • Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States6 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Study site

    Buffalo, New York

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Study site

    Myrtle Beach, South Carolina

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas

Other trials in United States

Canada2 sites

  • BC Cancer Agency-Vancouver

    Vancouver, British Columbia, V5Z 4E6

  • Study site

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: A QT/QTc and Multi-dose PK Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration- Resistant Prostate Cancer

The purpose of this study is to determine the effect of abiraterone acetate plus prednisone on the conduction of electric charges within the heart and to determine the blood levels of abiraterone acetate following administration in patients with metastatic castration-resistant prostate cancer.

Read the detailed description

This is an open-label (identity of assigned study drugs will be known) study to evaluate the effects of abiraterone acetate plus prednisone on the conduction of electric charges within the heart in male patients diagnosed with metastatic castration-resistant prostate cancer (a progressive form of prostate cancer that spreads to other parts of the body). At various time points outline in the protocol from Day -1 of Cycle 1 up to Day 2 of Cycle 2, patients will have electrocardiograms extracted from a 24 hour holter-monitor to evaluate the electrical activity of their heart. Efficacy will be assessed according to Prostate Cancer Working Group 2 and modified Response Evaluation Criteria In Solid Tumors criteria. Serial blood samples for pharmacokinetic analysis (how the drug concentrations change over time) will be collected and safety will be monitored throughout the study. Patients will take 1000 mg of abiraterone acetate once daily plus prednisone 5 mg twice daily orally (by mouth) until disease progression and will be followed up for up to 60 months.

Being tested
Abiraterone acetate, Prednisone
Keywords
Prostate neoplasms, Metastatic castration resistant prostate cancer, Abiraterone acetate, CB7630
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone acetateDrug

    Abiraterone acetate 1000 mg (4 x 250 mg tablets) administered orally once daily.

  • PrednisoneDrug

    Prednisone 5 mg tablets administered orally twice daily.

Study groups in NCT00910754
Study groupRoleWhat they receive
Abiraterone acetateExperimentalPatients will take 1000 mg of abiraterone acetate once daily plus prednisone 5 mg twice daily orally (by mouth) until disease progression.
Receives: Drug: Abiraterone acetate; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean maximal change in electrocardiogram QTc

    Measured: Baseline on Day -1 of Cycle 1 compared with Day 1 of Cycle 1, Cycle 2, Cycle 4 and every third cycle thereafter

Secondary outcomes (17)

  1. Number of participants with change from baseline electrocardiogram QTc >30 msec

    Measured: Pre-dose Cycles 1, 2, 4, and every third cycle after Cycle 4, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose, and end of study visit (4 weeks after last dose of study drug)

  2. Number of participants with change from baseline electrocardiogram QTc >60 msec

    Measured: Pre-dose Cycles 1, 2, 4, and every third cycle after Cycle 4, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose, and end of study visit (4 weeks after last dose of study drug)

  3. Number of participants affected by an adverse event

    Measured: Up to 30 days after the last dose of study medication

  4. Number of participants with change in cortrosyn stimulation test

    Measured: Baseline and end of study visit (4 weeks after last dose of study drug)

  5. Number of participants with change in serum blood levels of testosterone

    Measured: Baseline and end of study visit (4 weeks after last dose of study drug)

  6. Number of participants with change in adrenocorticotropic hormone

    Measured: Baseline and end of study visit (4 weeks after last dose of study drug)

  7. Mean plasma concentrations of abiraterone

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

  8. Maximum plasma concentrations of abiraterone

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

  9. Time to reach the maximum plasma concentration of abiraterone

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

  10. Area under the plasma-concentration-time curve from time 0 to the last quantifiable concentration of abiraterone

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

  11. Area under the plasma-concentration-time curve from time 0 to infinite time of abiraterone

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

  12. Elimination half-life of abiraterone

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

  13. Radiographic progression free survival

    Measured: Up to Month 60

  14. Overall survival

    Measured: Up to Month 60

  15. Number of participants with prostate specific antigen response

    Measured: Week 12

  16. Time to prostate specific antigen progression according to Prostate Cancer Working Group 2 criteria

    Measured: Up to Month 60

  17. Number of participants with objective radiographic response according to Prostate Cancer Working Group 2 criteria

    Measured: Up to Month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionNov 2009
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00910754
Sponsor's protocol ID
CR016942
Other IDs
COU-AA-006
Status last verified
Apr 2013
First submitted
28 May 2009
Last updated
12 Apr 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abiraterone acetate and Prednisone in people with Prostate Neoplasms, run by Janssen Research & Development, LLC at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean maximal change in electrocardiogram QTc (time frame: Baseline on Day -1 of Cycle 1 compared with Day 1 of Cycle 1, Cycle 2, Cycle 4 and every third cycle thereafter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00910754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2013.

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