ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer

Prostate Cancer Clinical Trial

— ARMOR1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959959
• Other study ID #: TOK-200-05
• Status: Completed
• Phase: Phase 1
• Start date: October 2009
• Est. completion date: August 2012

Study information

• Verified date: September 2020
• Source: Educational & Scientific LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Greenville Hospital System University Medical Center	Greenville	South Carolina
United States	Comprehensive Cancer Centers of Nevada & US Oncology Research	Las Vegas	Nevada
United States	UCLA	Los Angeles	California
United States	San Bernardino Urological Associates	San Bernardino	California
United States	University of Washington/Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Educational & Scientific LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Incidence of adverse events	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)	3 months
Secondary	Efficacy Measures	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	3 months