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A Phase I/II Study of HE3235 in Patients with Prostate Cancer
[Protocol 08-090]
- Full Title :
- PHASE I/II, OPEN-LABEL, DOSE RANGING STUDY OF THE SAFETY, TOLERANCE, PHARMACOKINETICS AND POTENTIAL ACTIVITY OF HE3235 WHEN ADMINISTERED ORALLY TO PATIENTS WITH PROSTATE CANCER
- Purpose :
HE3235, an investigational drug, is a manmade hormone that is similar to a natural hormone made in the adrenal glands. The adrenal glands are partly responsible for making testosterone, a hormone known to fuel prostate cancer growth. HE3235 appears to interfere with these growth pathways.
In laboratory studies, HE3235 was shown to slow the growth of prostate cancer. In this study, researchers want to find the highest dose of HE3235 that can be given safely in men with metastatic prostate cancer. The activity of the drug against prostate cancer will also be observed. HE3235 is taken orally (by mouth).
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have adenocarcinoma of the prostate that has progressed despite prior treatment that included at least one regimen of docetaxel-based therapy as well as hormonal therapy.
- Patients must have a serum testosterone level below 50 ng/mL.
- Patients must have recovered from the side effects of prior therapies.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Michael Morris at 646-422-4469.
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