ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer

ARMOR1: Phase 1, Open Label, Dose Escalation Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer

The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).

Inclusion Criteria:

• Signed informed consent form
• Confirmed cancer of the prostate
• Progressing disease in spite of androgen ablation therapy
• Able to swallow multiple capsules

Exclusion Criteria:

• Participation in another clinical trial < 4 weeks prior to enrollment

• Metastatic disease with one or more of the following:

  • Liver involvement
  • Bone pain associated with confirmed evidence of metastases
  • Non-hepatic visceral involvement

• The following medications:

  • Prior treatment with MDV3100, abiraterone, Provenge or TAK700
  • Prior treatment with ketoconazole
  • Prior treatment with chemotherapy
  • Prior radiation therapy completed ≤ 4 weeks prior to enrollment

• The following medical conditions:

  • Active angina pectoris
  • History of Hepatitis B or Hepatitis C
  • Known HIV infection
  • Ongoing hypertension

Note: There are additional inclusion and exclusion criteria. The clinical site center will determine if you are eligible. If you are not eligible for the trial, site staff will detail the reasons to you.