Study Drugs

I've been on a study drug for almost a year now. I read a post today, where a guy was on a study, but didn't say what study. I'm on Aragon-509. Anybody out there on it also? This is for non-met, but they have one for met PC.

[pjoshea13]

Hi Joe,

What has been your experience?

Aragon-509 [ARN-509] is an anti-androgen.  It's similar to Xtandi, which might make for slow accrual in trials.

Johnson & Johnson agreed to but Aragon for a $billion in 2013.

There seem to be 11 trials (7 recruiting, 2 not yet recruiting & 2 active):

clinicaltrials.gov/ct2/resu...

See story below.

-Patrick

prostatecancerinfolink.net/...

In September 2013, J&J initiated the development of a major, randomized, double-blind, Phase III clinical trial of ARN-509 (the so-called SPARTAN study) in the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC), aiming to enroll a total of about 1,200 patients (see also the relevant trial information on ClinicalTrials.gov).

In the SPARTAN study, eligible patients must have no sign of evident metastatic prostate cancer and must have either high risk for disease progression, defined as a PSA doubling time of ≤ 10 months while on continuous androgen deprivation therapy (ADT), or castration-resistant prostate cancer demonstrated while the patient has been on continuous ADT.

All patients will remain on their current therapy when they are enrolled into the SPARTAN trial, when they will then be randomized to additional treatment with either ARN-509 (at 240 mg once daily) or a placebo.

The SPARTAN study is enrolling patients at some 420 clinical sites around the world (in the USA and also in Australia, Canada, many European countries, Israel, Japan, New Zealand, Russia, and Taiwan), so enrolling in this study should not be difficult for interested patients. The fact that this trial is being carried out in men with nmCRPC or those likely to become metastatic or castration-resistant in the near future clearly makes this a “different” trial to many implemented in the past.

Current expectations are that the SPARTAN trial will be fully enrolled by late in 2016 and that final trial results can be expected some time in 2019. Patients are expected to be followed for up to 5 years, with a primary study endpoint of metastasis-free survival and a variety of secondary endpoints that include

Overall survival

Time to symptomatic progression

Time to initiation of cytotoxic chemotherapy

Progression-free survival

Time to evidence of metastasis

Changes in quality of life (based on the FACT-P and EQ-5D questionnaire scores)

Adverse events to ARN-509 and the placebo

A second large, randomized Phase III clinical trial of ARN-509 (the ATLAS study) was announced in August this year and is not yet enrolling patients. The ATLAS study has been designed to enroll men with high-risk prostate cancer who are scheduled for radiation therapy as their first-line (“primary”) treatment.

All patients must be scheduled for radiation therapy and will then be randomized to treatment with either ARN-509 (240 mg once daily) by mouth for 28 months plus a bicalutamide placebo by mouth, once daily, for 4 months from randomization or an ARN-509 placebo by mouth for 28 months plus bicalutamide (50 mg once daily), by mouth, for 4 months from randomization. All participants will also be treated with a luteinizing hormone releasing hormone (LHRH) agonist for 28 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.

The ATLAS trial is scheduled to enroll 1,500 patients, starting in February 2016. The primary study endpoint will again be metastasis-free survival with four secondary endpoints:

Time to local-regional recurrence

Time to castration-resistant prostate cancer (CRPC)

Time to distant metastasis

Overall survival (OS)

This study is again scheduled to enroll patients in the USA and other countries around the world. It is expected to be fully enrolled by 2020 with a study completion data in 2026.

J&J is clearly feeling confident about the potential of ARN-509 since two Phase III trials of this size represent a considerable financial investment.

[Hidden in reply to pjoshea13]

My experience with ARN-509 has been pretty boring. I began a year ago this month. The first several months the drug came in gelcap form, rather large, and had to take eight a day. Upset stomach was the norm. Now it comes in tablet form, and now only four a day, with no side effects. 

I can't say one way or another as to how it has affected my disease. Right now it seems my oncologist and Aragon people are not seeing eye to eye. My doc sees met in the spine, they don't see it. My doc sent me for a fluoride bone scan, which shows met. They were supposed to have a conference call to discuss this. I'll find out what transpired at my next visit on the sixth.

Joe

[Bogiedog]

Where is the study located?  What is the drug supposed to do?

[Bogiedog in reply to Bogiedog]

sorry... didn't read all the useful info before I commented.

[Hidden]

Let me say this before anyone goes on a trial drug, or selects a urolocist for that matter.  All seemed honky dory until the past few months.

After having routine imaging to track progression of my disease through the study people, my urologist looks at the imaging and sees progression. my urologist sends me for a fluoride bone scan. So, they have a pow-wow over this, and both remain at odds. My guy says I have in T1 &T2, the left coast guys say it's degenerative disease.

I quit both the study and the urologist. I'm going to the University of Penn/Virtua Cancer program in Philadelphia. Now, after I set up my move to U of Penn, I had complained to the higher ups about my care with this doc, and he boots me out of the practice. This was so unprofessional, I have no words to explain it. And please, no names. I don't want any attention over this.

Thanks all, Joe