TAK-700 to start Phase III clinical trial in mCRPC

According to a media release earlier today, Millennium and its parent company Takeda Pharmaceutical have initiated a randomized, double-blind, multi-center, Phase III clinical trial of TAK-700 (to be known in the future as Ortoronel) for the treatment of patients with chemotherapy-naïve, metastatic, castration-resistant prostate cancer (mCRPC).

This  study will randomize eligible patients to TAK-700 + prednisone or to placebo + prednisone. Primary endpoints for this study are overall survival (OS) and radiographic progression-free survival (PFS). Additional information about this trial is available on the ClinicalTrials.gov web site.

TAK-700 is a selective, oral, non-steroidal androgen synthesis inhibitor. In preclinical studies TAK-700 has been shown to bind to and inhibit the enzyme 17,20-lyase 1 in the testes and in the adrenal glands.

Later in the year, Millennium and Takeda plan to open enrollment of patients with docetaxel-refractory mCRPC into a second Phase III clinical trial of TAK-700. This second Phase III trial will also randomize patients to TAK-700 + prednisone or to placebo + prednisone.

Three other Phase II clinical trials of TAK-700 are still enrolling patients — one in men with non-metastatic CRPC and a rising PSA and a second in men with mCRPC.

Some time in the not too distant future, The “New” Prostate Cancer InfoLink expects Millennium to initiate at least one Phase III clinical trial in men with non-metastatic CRPC.

Along with abiraterone acetate and MDV3100, TAK-700 is another new pharmaceutical expected to add to the spectrum of pharmacotherapeutic agents that can offer potential survival benefits for men who are no longer responding to traditional hormone therapy and/or chemotherapy.

8 Responses

  1. Not that it shouldn’t be researched, but the life expectancy of “patients with docetaxel-refractory mCRPC” must be weeks to months, right? That’s a desperate group of patients. Informed consent has got to be pretty grim in that case. I hope they offer both the control and the test subject patients comprehensive hospice care.

  2. So they appear to be starting with the chemo-naive FIRST?! This is counter to the other compounds you mention above. How interesting.

  3. Dear Dave:

    Actually, no. Even men with chemotherapy-refractory prostate cancer have survival times of the order of 6 to 18 months today, largely because they become chemotherapy refractory long before they have the extensive metastasis that would have been customary 20 years ago. I am aware of chemo-refractory patients who still go to work and can have a pretty reasonable quality of life. This does not mean that it’s true for all of them of course.

    It is customary, for a trial of this type. that patients would meet eligibility criteria such that they had an expected survival of at least a few months. In the recently reported abiraterone trial in this exact group of patients, the men who received only a placebo + placebo lived for an average (median) of 10.9 months and the patients who received abiraterone lived for an average (median) of 14.8 months.

  4. I suppose one could see this as a signal of confidence in the drug’s activity.

  5. Oh. I would have thought that chemo-refractory patients would also be hormone refractory, and thus metastasis would be very likely. I guess I extrapolate from my deceased father’s experience. He had metastatic cancer by the time it became hormone refractory.

    Are there any conveniently online analyses of time until metastasis with different therapies?

  6. Dear Dave:

    The best I can offer you is this commentary from a few months back.

    I am aware of no recent, long-term study of the survival of men with progressive prostate cancer that followed the patients from initial use of hormone therapy through to death. And I am not aware of any study that has ever even considered doing this with a breakdown by all the differing possible therapies used along the way.

  7. Could any one give me some efficacy data on TAK700 for stage 4 prostate cancer?

  8. The most current data on the clinical use of TAK-700 in late stage prostate cancer are the data from a Phase I/II clinical trial presented in an abstract by Agus et al. at the annual meeting of the American Society for Clincial Oncology just a couple of months ago.

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