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

Sponsor:	Tokai Pharmaceuticals
Information provided by:	Tokai Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00959959

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: TOK-001	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	ARMOR1: Phase 1/2, Open Label, Dose Escalation, Selected Dose Comparison Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Tokai Pharmaceuticals:

Primary Outcome Measures:

Phase 1: Incidence of adverse events; Phase 2: Percent of patients with 50% or greater decrease in PSA from baseline. [ Time Frame: Phase 1: 1 month; Phase 2: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
650 mg TOK-001: Experimental	Drug: TOK-001 2 capsules (325 mg each), once per day
1300 mg TOK-001: Experimental	Drug: TOK-001 4 capsules (325 mg each), once per day
1950 mg TOK-001: Experimental	Drug: TOK-001 6 capsules (325 mg each), once per day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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, 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959959

Locations

United States, California
San Bernardino Urological Associates	Recruiting
San Bernardino, California, United States, 92404
Contact: Charity H. Hernandez, LVN 909-881-0555 charity@sburology.com
Contact: Roxie M. Cudahy, LVN 909 881 0555 roxie@sburology.com
Principal Investigator: Franklin Chu, MD
UCLA	Not yet recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Matthew Rettig, MD
United States, Maryland
Johns Hopkins Hospital	Not yet recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Mario Eisenberger, MD
United States, Massachusetts
Dana Farber Cancer Institute	Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Mary-Ellen Taplin, MD
United States, Nevada
Comprehensive Cancer Centers of Nevada & US Oncology Research	Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Elizabeth Petersen, RB, OCN 702-952-3426 elizabeth.petersen@usoncology.com
Contact: Norma Goode, RN, BSN 702 952 3400 ext 5425 norma.goode@usoncology.com
Principal Investigator: Nicholas Vogelzang, MD
United States, New York
Roswell Park Cancer Institute	Not yet recruiting
Buffalo, New York, United States, 14263
Principal Investigator: Roberto Pili, MD
United States, South Carolina
Greenville Hospital System University Medical Center	Recruiting
Greenville, South Carolina, United States, 29605
Contact: Lisa Johnson, RN, BSN 864-455-3774 ljohnson4@ghs.org
Contact: Jan Kueber, RN, BSN, OCN 864 455 3618 jkueber@ghs.org
Principal Investigator: Joe Stephenson, MD
United States, Washington
University of Washington/Seattle Cancer Care Alliance	Not yet recruiting
Seattle, Washington, United States, 98136
Contact: Deborah F. Chielens, RN 206-288-1189 dchielen@uw.edu
Contact: Jenny S. Martin, RN 206 288 7360 martinjs@uw.edu
Principal Investigator: R. B. Montgomery, MD

Sponsors and Collaborators

Tokai Pharmaceuticals

Investigators

Principal Investigator:	R. B. Montgomery, MD	University of Washington
Principal Investigator:	M. E. Taplin, MD	Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Tokai Pharmaceuticals ( Scott Chappel, Ph.D., COO/CSO )
Study ID Numbers:	TOK-200-05
Study First Received:	August 14, 2009
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00959959 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tokai Pharmaceuticals:

CRPC
HRPC
TOK-001
ARMOR
ARMOR1

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010