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: January 8, 2014
Last verified: September 2012

August 14, 2009
January 8, 2014
October 2009
August 2011   (final data collection date for primary outcome measure)
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)
Phase 1: Incidence of adverse events; Phase 2: Percent of patients with 50% or greater decrease in PSA from baseline. [ Time Frame: Phase 1: 1 month; Phase 2: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00959959 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer
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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: TOK-001
    2 capsules (325 mg each), once per day
    Other Name: Dose Group 1
  • Drug: TOK-001
    4 capsules (325 mg each), once per day
    Other Name: Dose Group 3
  • Drug: TOK-001
    6 capsules (325 mg each), once per day
    Other Name: Dose Group 4
  • Drug: TOK-001
    3 capsules (325 mg each), once per day
    Other Name: Dose Group 2
  • Drug: TOK-001
    3 capsules (325 mg each), once per day with supplement
    Other Name: Dose Group 5
  • Drug: TOK-001
    6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
    Other Name: Dose Group 6
  • Drug: TOK-001
    8 capsules (325 mg each), once per day
    Other Name: Dose Group 7
  • Drug: TOK-001
    8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
    Other Name: Dose Group 8
  • Experimental: 650 mg TOK-001
    Intervention: Drug: TOK-001
  • Experimental: 1300 mg TOK-001
    Intervention: Drug: TOK-001
  • Experimental: 1950 mg TOK-001
    Intervention: Drug: TOK-001
  • Experimental: 975 mg TOK-001
    Intervention: Drug: TOK-001
  • Experimental: 975 mg TOK-001, supplement
    Intervention: Drug: TOK-001
  • Experimental: 1950 mg TOK-001, split dose
    Intervention: Drug: TOK-001
  • Experimental: 2600 mg TOK-001
    Intervention: Drug: TOK-001
  • Experimental: 2600 mg TOK-001, split dose
    Intervention: Drug: TOK-001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
August 2012
August 2011   (final data collection date for primary outcome measure)

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.

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00959959
TOK-200-05
Yes
Tokai Pharmaceuticals
Tokai Pharmaceuticals
Not Provided
Principal Investigator: R. B. Montgomery, MD University of Washington
Principal Investigator: M. E. Taplin, MD Dana-Farber Cancer Institute
Tokai Pharmaceuticals
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP