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


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1: Incidence of adverse events

Outcome Description:

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)

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

R. B. Montgomery, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Food and Drug Administration

Study ID:

TOK-200-05

NCT ID:

NCT00959959

Start Date:

October 2009

Completion Date:

August 2012

Related Keywords:

  • Prostate Cancer
  • CRPC
  • HRPC
  • TOK-001
  • ARMOR
  • ARMOR1
  • Prostatic Neoplasms

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263
Dana Farber Cancer Institute Boston, Massachusetts  02115
UCLA Los Angeles, California  90095
San Bernardino Urological Associates San Bernardino, California  
University of Washington/Seattle Cancer Care Alliance Seattle, Washington  98109
Johns Hopkins Hospital Baltimore, Maryland  21287
Comprehensive Cancer Centers of Nevada & US Oncology Research Las Vegas, Nevada  89169
Greenville Hospital System University Medical Center Greenville, South Carolina  29605