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

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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).

Key facts

Study ID

NCT00959959

Run by

LTN PHARMACEUTICALS, INC.

People needed

49

Starts

2009-10-01

Expected to finish

2012-08-01

Last updated by the study team

2020-09-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• UCLA — Los Angeles, California, United States
• San Bernardino Urological Associates — San Bernardino, California, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Comprehensive Cancer Centers of Nevada & US Oncology Research — Las Vegas, Nevada, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Greenville Hospital System University Medical Center — Greenville, South Carolina, United States
• University of Washington/Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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