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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: TOK-001
* Drug: TOK-001
* Drug: TOK-001
* Drug: TOK-001
* Drug: TOK-001
* Drug: TOK-001
* Drug: TOK-001
* Drug: TOK-001


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 650 mg TOK-001<br> | Drug: TOK-001<br>* 2 capsules (325 mg each), once per day<br>* Other names: Dose Group 1;|
| Experimental: 1300 mg TOK-001<br> | Drug: TOK-001<br>* 4 capsules (325 mg each), once per day<br>* Other names: Dose Group 3;|
| Experimental: 1950 mg TOK-001<br> | Drug: TOK-001<br>* 6 capsules (325 mg each), once per day<br>* Other names: Dose Group 4;|
| Experimental: 975 mg TOK-001<br> | Drug: TOK-001<br>* 3 capsules (325 mg each), once per day<br>* Other names: Dose Group 2;|
| Experimental: 975 mg TOK-001, supplement<br> | Drug: TOK-001<br>* 3 capsules (325 mg each), once per day with supplement<br>* Other names: Dose Group 5;|
| Experimental: 1950 mg TOK-001, split dose<br> | Drug: TOK-001<br>* 6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)<br>* Other names: Dose Group 6;|
| Experimental: 2600 mg TOK-001<br> | Drug: TOK-001<br>* 8 capsules (325 mg each), once per day<br>* Other names: Dose Group 7;|
| Experimental: 2600 mg TOK-001, split dose<br> | Drug: TOK-001<br>* 8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)<br>* Other names: Dose Group 8;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Incidence of adverse events | 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) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Measures | Efficacy will be assessed by evaluation of change in PSA level, changes from baseline in CT/MRI and bone scans, response rate RECIST criteria and additional special laboratories | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRPC, HRPC, TOK-001, ARMOR, ARMOR1, ESL, Galeterone