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Completed

NCT Number: NCT00959959

ARMOR1: Study of TOK-001 to Treat 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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

UCLA, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TOK-001

Drug

2 capsules (325 mg each), once per day

Other names: Dose Group 1

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

LTN PHARMACEUTICALS, INC.

Industry

Registry information

Official study title

ARMOR1: Phase 1, Open Label, Dose Escalation Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer

Acronym: ARMOR1

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Aug 17, 2009
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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