Status:
COMPLETED
ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer
Lead Sponsor:
LTN PHARMACEUTICALS, INC.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- Signed informed consent form
- Confirmed cancer of the prostate
- Progressing disease in spite of androgen ablation therapy
- Able to swallow multiple capsules
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00959959
Start Date
October 1 2009
End Date
August 1 2012
Last Update
September 4 2020
Active Locations (8)
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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