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
Treatment Plan
Arm/Group Label
Arm/Group Type
Arm/Group Description
1300 mg TOK-001
Experimental
Not Provided
1950 mg TOK-001
Experimental
Not Provided
1950 mg TOK-001, split dose
Experimental
Not Provided
2600 mg TOK-001
Experimental
Not Provided
650 mg TOK-001
Experimental
Not Provided
975 mg TOK-001
Experimental
Not Provided
975 mg TOK-001, supplement
Experimental
Not Provided
Phase 2 Arm 1
Experimental
Dose TBD
Phase 2 Arm 2
Experimental
Dose TBD
Intervention(s)
TOK-001,
Patient eligibility
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.
For detailed patient eligibility criteria for this clinical trial, please click here to show/hide
