Trial | NCT00959959  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    galeterone ...

  • Study Participants

    49
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).
Study Started
Oct 31
2009
Primary Completion
Aug 31
2011
Study Completion
Aug 31
2012
Last Update
Sep 04
2020

Drug TOK-001

2 capsules (325 mg each), once per day

  • Other names: Dose Group 1

Drug TOK-001

4 capsules (325 mg each), once per day

  • Other names: Dose Group 3

Drug TOK-001

6 capsules (325 mg each), once per day

  • Other names: Dose Group 4

Drug TOK-001

3 capsules (325 mg each), once per day

  • Other names: Dose Group 2

Drug TOK-001

3 capsules (325 mg each), once per day with supplement

  • Other names: Dose Group 5

Drug TOK-001

6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)

  • Other names: Dose Group 6

Drug TOK-001

8 capsules (325 mg each), once per day

  • Other names: Dose Group 7

Drug TOK-001

8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)

  • Other names: Dose Group 8

650 mg TOK-001 Experimental

1300 mg TOK-001 Experimental

1950 mg TOK-001 Experimental

975 mg TOK-001 Experimental

975 mg TOK-001, supplement Experimental

1950 mg TOK-001, split dose Experimental

2600 mg TOK-001 Experimental

2600 mg TOK-001, split dose Experimental

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, 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.
No Results Posted