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

September 2, 2020 updated by: LTN PHARMACEUTICALS, INC.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 650 mg TOK-001
Drug: TOK-001
2 capsules (325 mg each), once per day
Other Names:
  • Dose Group 1
Drug: TOK-001
4 capsules (325 mg each), once per day
Other Names:
  • Dose Group 3
Drug: TOK-001
6 capsules (325 mg each), once per day
Other Names:
  • Dose Group 4
Drug: TOK-001
3 capsules (325 mg each), once per day
Other Names:
  • Dose Group 2
Drug: TOK-001
3 capsules (325 mg each), once per day with supplement
Other Names:
  • Dose Group 5
Drug: TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
Other Names:
  • Dose Group 6
Drug: TOK-001
8 capsules (325 mg each), once per day
Other Names:
  • Dose Group 7
Drug: TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Other Names:
  • Dose Group 8
Experimental: 1300 mg TOK-001
Drug: TOK-001
2 capsules (325 mg each), once per day
Other Names:
  • Dose Group 1
Drug: TOK-001
4 capsules (325 mg each), once per day
Other Names:
  • Dose Group 3
Drug: TOK-001
6 capsules (325 mg each), once per day
Other Names:
  • Dose Group 4
Drug: TOK-001
3 capsules (325 mg each), once per day
Other Names:
  • Dose Group 2
Drug: TOK-001
3 capsules (325 mg each), once per day with supplement
Other Names:
  • Dose Group 5
Drug: TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
Other Names:
  • Dose Group 6
Drug: TOK-001
8 capsules (325 mg each), once per day
Other Names:
  • Dose Group 7
Drug: TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Other Names:
  • Dose Group 8
Experimental: 1950 mg TOK-001
Drug: TOK-001
2 capsules (325 mg each), once per day
Other Names:
  • Dose Group 1
Drug: TOK-001
4 capsules (325 mg each), once per day
Other Names:
  • Dose Group 3
Drug: TOK-001
6 capsules (325 mg each), once per day
Other Names:
  • Dose Group 4
Drug: TOK-001
3 capsules (325 mg each), once per day
Other Names:
  • Dose Group 2
Drug: TOK-001
3 capsules (325 mg each), once per day with supplement
Other Names:
  • Dose Group 5
Drug: TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
Other Names:
  • Dose Group 6
Drug: TOK-001
8 capsules (325 mg each), once per day
Other Names:
  • Dose Group 7
Drug: TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Other Names:
  • Dose Group 8
Experimental: 975 mg TOK-001
Drug: TOK-001
2 capsules (325 mg each), once per day
Other Names:
  • Dose Group 1
Drug: TOK-001
4 capsules (325 mg each), once per day
Other Names:
  • Dose Group 3
Drug: TOK-001
6 capsules (325 mg each), once per day
Other Names:
  • Dose Group 4
Drug: TOK-001
3 capsules (325 mg each), once per day
Other Names:
  • Dose Group 2
Drug: TOK-001
3 capsules (325 mg each), once per day with supplement
Other Names:
  • Dose Group 5
Drug: TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
Other Names:
  • Dose Group 6
Drug: TOK-001
8 capsules (325 mg each), once per day
Other Names:
  • Dose Group 7
Drug: TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Other Names:
  • Dose Group 8
Experimental: 975 mg TOK-001, supplement
Drug: TOK-001
2 capsules (325 mg each), once per day
Other Names:
  • Dose Group 1
Drug: TOK-001
4 capsules (325 mg each), once per day
Other Names:
  • Dose Group 3
Drug: TOK-001
6 capsules (325 mg each), once per day
Other Names:
  • Dose Group 4
Drug: TOK-001
3 capsules (325 mg each), once per day
Other Names:
  • Dose Group 2
Drug: TOK-001
3 capsules (325 mg each), once per day with supplement
Other Names:
  • Dose Group 5
Drug: TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
Other Names:
  • Dose Group 6
Drug: TOK-001
8 capsules (325 mg each), once per day
Other Names:
  • Dose Group 7
Drug: TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Other Names:
  • Dose Group 8
Experimental: 1950 mg TOK-001, split dose
Drug: TOK-001
2 capsules (325 mg each), once per day
Other Names:
  • Dose Group 1
Drug: TOK-001
4 capsules (325 mg each), once per day
Other Names:
  • Dose Group 3
Drug: TOK-001
6 capsules (325 mg each), once per day
Other Names:
  • Dose Group 4
Drug: TOK-001
3 capsules (325 mg each), once per day
Other Names:
  • Dose Group 2
Drug: TOK-001
3 capsules (325 mg each), once per day with supplement
Other Names:
  • Dose Group 5
Drug: TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
Other Names:
  • Dose Group 6
Drug: TOK-001
8 capsules (325 mg each), once per day
Other Names:
  • Dose Group 7
Drug: TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Other Names:
  • Dose Group 8
Experimental: 2600 mg TOK-001
Drug: TOK-001
2 capsules (325 mg each), once per day
Other Names:
  • Dose Group 1
Drug: TOK-001
4 capsules (325 mg each), once per day
Other Names:
  • Dose Group 3
Drug: TOK-001
6 capsules (325 mg each), once per day
Other Names:
  • Dose Group 4
Drug: TOK-001
3 capsules (325 mg each), once per day
Other Names:
  • Dose Group 2
Drug: TOK-001
3 capsules (325 mg each), once per day with supplement
Other Names:
  • Dose Group 5
Drug: TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
Other Names:
  • Dose Group 6
Drug: TOK-001
8 capsules (325 mg each), once per day
Other Names:
  • Dose Group 7
Drug: TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Other Names:
  • Dose Group 8
Experimental: 2600 mg TOK-001, split dose
Drug: TOK-001
2 capsules (325 mg each), once per day
Other Names:
  • Dose Group 1
Drug: TOK-001
4 capsules (325 mg each), once per day
Other Names:
  • Dose Group 3
Drug: TOK-001
6 capsules (325 mg each), once per day
Other Names:
  • Dose Group 4
Drug: TOK-001
3 capsules (325 mg each), once per day
Other Names:
  • Dose Group 2
Drug: TOK-001
3 capsules (325 mg each), once per day with supplement
Other Names:
  • Dose Group 5
Drug: TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
Other Names:
  • Dose Group 6
Drug: TOK-001
8 capsules (325 mg each), once per day
Other Names:
  • Dose Group 7
Drug: TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Other Names:
  • Dose Group 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LTN PHARMACEUTICALS, INC.

Investigators

  • Principal Investigator: R. B. Montgomery, MD, University of Washington
  • Principal Investigator: M. E. Taplin, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOK-200-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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