ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer
- Registration Number
- NCT00959959
- Lead Sponsor
- LTN PHARMACEUTICALS, INC.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 49
- Signed informed consent form
- Confirmed cancer of the prostate
- Progressing disease in spite of androgen ablation therapy
- Able to swallow multiple capsules
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1950 mg TOK-001, split dose TOK-001 - 2600 mg TOK-001 TOK-001 - 2600 mg TOK-001, split dose TOK-001 - 650 mg TOK-001 TOK-001 - 1300 mg TOK-001 TOK-001 - 1950 mg TOK-001 TOK-001 - 975 mg TOK-001 TOK-001 - 975 mg TOK-001, supplement TOK-001 -
- Primary Outcome Measures
Name Time Method Phase 1: Incidence of adverse events 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 Outcome Measures
Name Time Method Efficacy Measures 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
Trial Locations
- Locations (8)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
UCLA
🇺🇸Los Angeles, California, United States
San Bernardino Urological Associates
🇺🇸San Bernardino, California, United States
Comprehensive Cancer Centers of Nevada & US Oncology Research
🇺🇸Las Vegas, Nevada, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Greenville Hospital System University Medical Center
🇺🇸Greenville, South Carolina, United States
University of Washington/Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States