Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resista… (NCT01171898) | Clinical Trial Compass
CompletedPhase 1/2
Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)
United States127 participantsStarted 2010-07-26
Plain-language summary
The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of ARN-509.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically or cytologically proven prostate cancer with high risk for development of metastases, defined as either a PSA value \>=8 ng/mL within the last 3 months or PSA Doubling Time \<=10 months
. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
. Castrate levels of serum testosterone of less than or equal to 50 ng/dL
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
. A life expectancy of at least 3 months
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 1/2 trial testing apalutamide (ARN-509) in castration-resistant prostate cancer — since it's now completed, can you tell me what the safety and PSA response results showed, and whether those results are relevant to my specific situation?
2The trial measured whether PSA dropped by 50% or more at 12 weeks — is PSA reduction at that timepoint a reliable indicator of meaningful benefit for someone with my stage of prostate cancer, or is it just one piece of the picture?
3Since this was an early-phase study combining Phase 1 and Phase 2, what does that mean for how much we know about apalutamide's long-term safety compared to treatments that have gone through larger Phase 3 trials?
4Apalutamide has since been approved for certain types of prostate cancer — based on everything that's been learned since this trial, do you think it could be a relevant treatment option for me, and how would it compare to the standard treatments available now?
5Given that this trial enrolled men with castration-resistant prostate cancer, is my disease at a stage where this kind of hormone-resistant treatment would even apply, or should we be focused on other approaches first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1 and 2: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) at Week 12
. Distant metastases, including CNS and vertebral or meningeal involvement
. Prior treatment with MDV3100
. Prior treatment with abiraterone
. Prior treatment with ketoconazole
. Concurrent treatment with medications known to have seizure potential
. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible.
. QTc \> 450 msec
. History of seizure or condition that may predispose to seizure