ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer
NCT ID: NCT00959959
Last Updated: 2020-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2009-10-31
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer
NCT07258407
A Study of TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer
NCT02141659
Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer
NCT00771017
A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
NCT01709734
Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer
NCT02566772
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
650 mg TOK-001
TOK-001
2 capsules (325 mg each), once per day
1300 mg TOK-001
TOK-001
4 capsules (325 mg each), once per day
1950 mg TOK-001
TOK-001
6 capsules (325 mg each), once per day
975 mg TOK-001
TOK-001
3 capsules (325 mg each), once per day
975 mg TOK-001, supplement
TOK-001
3 capsules (325 mg each), once per day with supplement
1950 mg TOK-001, split dose
TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
2600 mg TOK-001
TOK-001
8 capsules (325 mg each), once per day
2600 mg TOK-001, split dose
TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TOK-001
2 capsules (325 mg each), once per day
TOK-001
4 capsules (325 mg each), once per day
TOK-001
6 capsules (325 mg each), once per day
TOK-001
3 capsules (325 mg each), once per day
TOK-001
3 capsules (325 mg each), once per day with supplement
TOK-001
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
TOK-001
8 capsules (325 mg each), once per day
TOK-001
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Confirmed cancer of the prostate
* Progressing disease in spite of androgen ablation therapy
* Able to swallow multiple capsules
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LTN PHARMACEUTICALS, INC.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
R. B. Montgomery, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
M. E. Taplin, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA
Los Angeles, California, United States
San Bernardino Urological Associates
San Bernardino, California, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TOK-200-05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.