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

This study has been completed.
Information provided by (Responsible Party):
Tokai Pharmaceuticals Identifier:
First received: August 14, 2009
Last updated: January 8, 2014
Last verified: September 2012
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).

Condition Intervention Phase
Prostate Cancer Drug: TOK-001 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ARMOR1: Phase 1, Open Label, Dose Escalation Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Tokai Pharmaceuticals:

Primary Outcome Measures:
  • Phase 1: Incidence of adverse events [ Time Frame: 3 months ]
    Safety will be assessed by incidence of AEs and change from baseline in the following additional safety parameters: clinical laboratory assessments, physical examination, vital signs, and 12 lead electrocardiograms (ECGs)

Secondary Outcome Measures:
  • Efficacy Measures [ Time Frame: 3 months ]
    Efficacy will be assessed by evaluation of change in PSA level, changes from baseline in CT/MRI and bone scans, response rate RECIST criteria and additional special laboratories

Enrollment: 49
Study Start Date: October 2009
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 650 mg TOK-001 Drug: TOK-001
2 capsules (325 mg each), once per day
Other Name: Dose Group 1
Experimental: 1300 mg TOK-001 Drug: TOK-001
4 capsules (325 mg each), once per day
Other Name: Dose Group 3
Experimental: 1950 mg TOK-001 Drug: TOK-001
6 capsules (325 mg each), once per day
Other Name: Dose Group 4
Experimental: 975 mg TOK-001 Drug: TOK-001
3 capsules (325 mg each), once per day
Other Name: Dose Group 2
Experimental: 975 mg TOK-001, supplement Drug: TOK-001
3 capsules (325 mg each), once per day with supplement
Other Name: Dose Group 5
Experimental: 1950 mg TOK-001, split dose Drug: TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
Other Name: Dose Group 6
Experimental: 2600 mg TOK-001 Drug: TOK-001
8 capsules (325 mg each), once per day
Other Name: Dose Group 7
Experimental: 2600 mg TOK-001, split dose Drug: TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Other Name: Dose Group 8


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00959959

United States, California
Los Angeles, California, United States, 90095
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Nevada
Comprehensive Cancer Centers of Nevada & US Oncology Research
Las Vegas, Nevada, United States, 89169
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, South Carolina
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States, 29605
United States, Washington
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States, 98136
Sponsors and Collaborators
Tokai Pharmaceuticals
Principal Investigator: R. B. Montgomery, MD University of Washington
Principal Investigator: M. E. Taplin, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Tokai Pharmaceuticals Identifier: NCT00959959     History of Changes
Other Study ID Numbers: TOK-200-05
Study First Received: August 14, 2009
Last Updated: January 8, 2014

Keywords provided by Tokai Pharmaceuticals:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on June 22, 2017