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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TOK-001
TOK-001
TOK-001
TOK-001
TOK-001
TOK-001
TOK-001
TOK-001
Sponsored by
LTN PHARMACEUTICALS, INC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring CRPC, HRPC, TOK-001, ARMOR, ARMOR1, ESL, Galeterone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA
  • San Bernardino Urological Associates
  • Johns Hopkins Hospital
  • Dana Farber Cancer Institute
  • Comprehensive Cancer Centers of Nevada & US Oncology Research
  • Roswell Park Cancer Institute
  • Greenville Hospital System University Medical Center
  • University of Washington/Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

650 mg TOK-001

1300 mg TOK-001

1950 mg TOK-001

975 mg TOK-001

975 mg TOK-001, supplement

1950 mg TOK-001, split dose

2600 mg TOK-001

2600 mg TOK-001, split dose

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2009
Last Updated
September 2, 2020
Sponsor
LTN PHARMACEUTICALS, INC.
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1. Study Identification

Unique Protocol Identification Number
NCT00959959
Brief Title
ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer
Acronym
ARMOR1
Official Title
ARMOR1: Phase 1, Open Label, Dose Escalation Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LTN PHARMACEUTICALS, INC.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
CRPC, HRPC, TOK-001, ARMOR, ARMOR1, ESL, Galeterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
650 mg TOK-001
Arm Type
Experimental
Arm Title
1300 mg TOK-001
Arm Type
Experimental
Arm Title
1950 mg TOK-001
Arm Type
Experimental
Arm Title
975 mg TOK-001
Arm Type
Experimental
Arm Title
975 mg TOK-001, supplement
Arm Type
Experimental
Arm Title
1950 mg TOK-001, split dose
Arm Type
Experimental
Arm Title
2600 mg TOK-001
Arm Type
Experimental
Arm Title
2600 mg TOK-001, split dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TOK-001
Other Intervention Name(s)
Dose Group 1
Intervention Description
2 capsules (325 mg each), once per day
Intervention Type
Drug
Intervention Name(s)
TOK-001
Other Intervention Name(s)
Dose Group 3
Intervention Description
4 capsules (325 mg each), once per day
Intervention Type
Drug
Intervention Name(s)
TOK-001
Other Intervention Name(s)
Dose Group 4
Intervention Description
6 capsules (325 mg each), once per day
Intervention Type
Drug
Intervention Name(s)
TOK-001
Other Intervention Name(s)
Dose Group 2
Intervention Description
3 capsules (325 mg each), once per day
Intervention Type
Drug
Intervention Name(s)
TOK-001
Other Intervention Name(s)
Dose Group 5
Intervention Description
3 capsules (325 mg each), once per day with supplement
Intervention Type
Drug
Intervention Name(s)
TOK-001
Other Intervention Name(s)
Dose Group 6
Intervention Description
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
Intervention Type
Drug
Intervention Name(s)
TOK-001
Other Intervention Name(s)
Dose Group 7
Intervention Description
8 capsules (325 mg each), once per day
Intervention Type
Drug
Intervention Name(s)
TOK-001
Other Intervention Name(s)
Dose Group 8
Intervention Description
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Primary Outcome Measure Information:
Title
Phase 1: Incidence of adverse events
Description
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 Outcome Measure Information:
Title
Efficacy Measures
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. B. Montgomery, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M. E. Taplin, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
San Bernardino Urological Associates
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada & US Oncology Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Greenville Hospital System University Medical Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
University of Washington/Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98136
Country
United States

12. IPD Sharing Statement

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

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