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CompletedNCT00959959ARMOR1Updated Sep 4, 2020

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

A Phase 1 interventional study of TOK-001 and TOK-001 in Prostate Cancer, sponsored by LTN PHARMACEUTICALS, INC.. Completed at 8 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-04.

Sponsored by LTN PHARMACEUTICALS, INC. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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).

02

Conditions studied

  • Prostate Cancer

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Keywords

  • CRPC
  • HRPC
  • TOK-001
  • ARMOR
  • ARMOR1
  • ESL
  • Galeterone
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 49 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

LTN PHARMACEUTICALS, INC. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    650 mg TOK-001

    Drug: TOK-001

  • Experimental
    1300 mg TOK-001

    Drug: TOK-001

  • Experimental
    1950 mg TOK-001

    Drug: TOK-001

  • Experimental
    975 mg TOK-001

    Drug: TOK-001

  • Experimental
    975 mg TOK-001, supplement

    Drug: TOK-001

  • Experimental
    1950 mg TOK-001, split dose

    Drug: TOK-001

  • Experimental
    2600 mg TOK-001

    Drug: TOK-001

  • Experimental
    2600 mg TOK-001, split dose

    Drug: TOK-001

Interventions

  • DrugTOK-001

    2 capsules (325 mg each), once per day

    Also known as: Dose Group 1

  • DrugTOK-001

    4 capsules (325 mg each), once per day

    Also known as: Dose Group 3

  • DrugTOK-001

    6 capsules (325 mg each), once per day

    Also known as: Dose Group 4

  • DrugTOK-001

    3 capsules (325 mg each), once per day

    Also known as: Dose Group 2

  • DrugTOK-001

    3 capsules (325 mg each), once per day with supplement

    Also known as: Dose Group 5

  • DrugTOK-001

    6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)

    Also known as: Dose Group 6

  • DrugTOK-001

    8 capsules (325 mg each), once per day

    Also known as: Dose Group 7

  • DrugTOK-001

    8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)

    Also known as: Dose Group 8

06

What researchers measure

Primary outcomes

  1. Phase 1: Incidence of adverse events

    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)

    Time frame: 3 months

Secondary outcomes

  1. Efficacy Measures

    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

    Time frame: 3 months

07

Study locations

8 sites
  • UCLA
    Los Angeles, California 90095, United States
  • San Bernardino Urological Associates
    San Bernardino, California 92404, United States
  • Johns Hopkins Hospital
    Baltimore, Maryland 21231, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Comprehensive Cancer Centers of Nevada & US Oncology Research
    Las Vegas, Nevada 89169, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Greenville Hospital System University Medical Center
    Greenville, South Carolina 29605, United States
  • University of Washington/Seattle Cancer Care Alliance
    Seattle, Washington 98136, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00959959
Lead sponsor
LTN PHARMACEUTICALS, INC.
Responsible party
Sponsor
First posted
Aug 17, 2009
Start date
Oct 2009
Primary completion
Aug 2011
Completion
Aug 2012
Last update
Sep 4, 2020

Study contacts

R. B. Montgomery, MD
principal investigator · University of Washington
M. E. Taplin, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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