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

Sponsor

Educational & Scientific LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00959959

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: TOK-001 Drug: TOK-001 Drug: TOK-001 Drug: TOK-001 Drug: TOK-001 Drug: TOK-001 Drug: TOK-001 Drug: TOK-001	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 650 mg TOK-001	Drug: TOK-001 2 capsules (325 mg each), once per day Other Names: Dose Group 1
Experimental: 1300 mg TOK-001	Drug: TOK-001 4 capsules (325 mg each), once per day Other Names: Dose Group 3
Experimental: 1950 mg TOK-001	Drug: TOK-001 6 capsules (325 mg each), once per day Other Names: Dose Group 4
Experimental: 975 mg TOK-001	Drug: TOK-001 3 capsules (325 mg each), once per day Other Names: Dose Group 2
Experimental: 975 mg TOK-001, supplement	Drug: TOK-001 3 capsules (325 mg each), once per day with supplement Other Names: Dose Group 5
Experimental: 1950 mg TOK-001, split dose	Drug: TOK-001 6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner) Other Names: Dose Group 6
Experimental: 2600 mg TOK-001	Drug: TOK-001 8 capsules (325 mg each), once per day Other Names: Dose Group 7
Experimental: 2600 mg TOK-001, split dose	Drug: TOK-001 8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner) Other Names: Dose Group 8

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095
2	San Bernardino Urological Associates	San Bernardino	California	United States	92404
3	Johns Hopkins Hospital	Baltimore	Maryland	United States	21231
4	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
5	Comprehensive Cancer Centers of Nevada & US Oncology Research	Las Vegas	Nevada	United States	89169
6	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
7	Greenville Hospital System University Medical Center	Greenville	South Carolina	United States	29605
8	University of Washington/Seattle Cancer Care Alliance	Seattle	Washington	United States	98136