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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00959959

Acronym

ARMOR1

Enrollment

Registered

2009-08-17

Start date

2009-10-31

Completion date

2012-08-31

Last updated

2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

CRPC, HRPC, TOK-001, ARMOR, ARMOR1, ESL, Galeterone

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).

Interventions

DRUGTOK-001

2 capsules (325 mg each), once per day

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026