“Compassionate use” trial of abiraterone acetate in mCRPC to start soon

As previously reported, a “compassionate use” study of abiraterone actetate is expected to start shortly (first in the USA and then in other countries).

The protocol for this clinical trial is now available on the ClinicalTrials.gov web site. Eligible patients must clearly meet the following criteria (which are similar to those for patients who participated in the first Phase III clinical trial of abiraterone acetate, the results of which were announced yesterday):

  • Evident, metastatic, castration-resistant prostate cancer
  • Progressive disease after treatment with one or two chemotherapy regimens (of which one must have been based on a taxane such as docetaxel/Taxotere)
  • Not eligible for enrollment in any other ongoing clinical research study of abiraterone acetate
  • Over 18 years of age

The trial will be designed to monitor side effects of treatment with abiraterone + prednisone. All patients will receive continuous daily treatment with four 250-mg tablets of abiraterone acetate, taken orally at least 1 hour before a meal or 2 hours after a meal. Patients will also take 5 mg of oral prednisone, twice a day. At the time of disease progression, abiraterone will be discontinued and the dose of prednisone will be reduced if clinically appropriate.

Although this study is not yet enrolling patients, you can check the trial protocol on line to see when and where enrollment starts or you can e-mail info1@veritasmedicine.com and ask to be informed about when the trial is enrolling patients at a center close to you.

5 Responses

  1. I would like to know when and where enrollment will be open for “Compassionate use” trial of abiraterone with acetate: ClinicalTrials.gov Identifier:NCT01217697. I have been told by prostate specialists at Tulane University and Taussig Cancer Institute of Cleveland Clinic that this is a drug I now need. I will meet the criteria. I live in central Kentucky and could travel a reasonable distance for treatment.

  2. Dear Mr. Brown:

    According to the trial protocol on the ClinicalTrials.gov web site, this trial is still not open for recruitment. However, if you e-mail info1@veritasmedicine.com and ask them to let you know where and when specific centers are opening for recruitment, I believe they will contact you as soon as appropriate information is available.

  3. Hi,

    My dad is really suffering with prostate cancer, it seems like abiraterone might be his best chance. My mum has been desperately trying to get hold of abiraterone on compassionate grounds. I was very hopeful that you might have some contacts or advice. My dad lives in the UK.

    Thank you, Jane

  4. Dear Jane:

    I am sorry to hear about your Dad. However, the only way we know how to get abiraterone for compassionate use is through the trial described above and through the e-mail address in the message for Mr. Brown. We simply do not know when it might be available in the UK.

    I would point out that your Dad may be eligible for clinical trials of a couple of other drugs that could turn out to be as good as abiraterone (or maybe better). These are MDV3100 and TAK-700.

  5. Thank you for your message. My Dad has been on the MDV3100. The TAK-700 looks promising as an option. Forever hopeful, Thank you, Jane

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