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Protocol No. UW17031

Principal Investigator Kyriakopoulos, Christos

Phase I

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase I Study of PCUR-101 in Combination with Androgen Suppression Therapy in the Treatment of Patients with Metastatic Castrate-Resistant Prostate Cancer

Objective The main purpose of this study is to determine a safe dose of an experimental drug called PCUR-101 in patients with metastatic castration-resistant prostate cancer (CRPC) who maintain low levels of testosterone (in other words, “castration”). A secondary purpose of this study is to determine if PCUR-101 exhibits antitumor activity. PCUR-101 is an investigational drug, meaning it has not been approved by the U.S. Food & Drug Administration (FDA).

Treatment PCUR-101 is an investigational drug, meaning it has not been approved by the U.S. Food & Drug Administration (FDA). PCUR-101 is created in a laboratory in an oil-based formula for administration orally (by mouth) based on the naturally occurring compound call plumbagin. Plumbagin was initially derived from various plants used in traditional medicine across Asia and Europe. Plumbagin has displayed anti-tumor activities in cells and in animals in the past and has demonstrated an effect on prostate cancer cells in the laboratory. PCUR-101, the lab created version of plumbagin, will be the study drug in this study. Testing in the laboratory and in animals has shown that PCUR-101 combined with drugs that lower testosterone production increased the effect of the drugs together. It is not currently known how the study drug works in the body. This is the first time this study drug will be given to humans.

Description There will be up to six cohorts (groups) of up to 6 subjects per group that will receive different dose levels of the study drug (PCUR-101). The group you participate in will depend upon when you join the study, and what the study doctor learns about dose limiting toxicity outcomes of the study drug from subjects already in the study. Whichever group you are in, you will be given an adequate supply of the study drug to take at home each morning until your next scheduled study visit. You will keep track of this in a study diary that you will bring to each study visit.

Key Eligibility
  • Histologically confirmed diagnosis of metastatic castration-resistant prostate cancer (CRPC)
  • All patients must be receiving standard of care androgen deprivation treatment (surgical castration vs. LHRH agonist of antagonist treatment); subjects receiving LHRH agonist or antagonist must continue treatment throughout the time of the study
  • Progressive disease while receiving androgen deprivation therapy
  • Patients may or may not have been treated previously with a nonsteroidal antiandrogen, such as flutamide, bicalutamide or nilutamide. For patients previously treated with an antiandrogen, they must be off treatment for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to treatment start and must have shown PSA progression after discontinuing the anti-androgen
  • Patients must have been previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria
  • Patients may have received no more than one prior course of cytotoxic chemotherapy in the castration-resistant setting. Prior therapy with docetaxel for hormone-sensitive prostate cancer (HSPC) is permissible if stopped at least 12 weeks prior to treatment start
  • Asymptomatic or minimally symptomatic pain from prostate cancer at screening
  • Patients with visceral metastasis excluding lymph nodes are excluded
  • Patients with use of opiate analgesics for prostate cancer pain within 4 week of treatment start are excluded
  • Patients who have had more than one sequential second generation AR-directed therapy (e.g. abiraterone or enzalutamide) in the castration-resistant setting are excluded
  • Patients who have received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks prior to treatment start are excluded
  • Patients who have a history of bleeding disorder are excluded
  • Patients who have a history of seizure disorder are excluded
  • Patients on concomitant use of therapeutic anticoagulation are excluded
  • Patients who have received external beam radiation therapy within 4 weeks of treatment start are excluded

Applicable Disease Sites Prostate

Drugs Involved PCUR-101; Plumbagin (PCUR-101)

Status Open

Participating Institutions UW Hospital and Clinics