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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tokai Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00959959
First received: August 14, 2009
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Tokai Pharmaceuticals:

Primary Outcome Measures:
  • Phase 1: Incidence of adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959959

Locations
United States, California
UCLA
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
Investigators
Principal Investigator: R. B. Montgomery, MD University of Washington
Principal Investigator: M. E. Taplin, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Tokai Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00959959     History of Changes
Other Study ID Numbers: TOK-200-05
Study First Received: August 14, 2009
Last Updated: September 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Tokai Pharmaceuticals:
CRPC
HRPC
TOK-001
ARMOR
ARMOR1

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013