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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOK-001 | Drug | 2 capsules (325 mg each), once per day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participation in another clinical trial < 4 weeks prior to enrollment
Metastatic disease with one or more of the following:
The following medications:
The following medical conditions:
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.
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| Name | Affiliation | Role |
|---|---|---|
| R. B. Montgomery, MD | University of Washington | Principal Investigator |
| M. E. Taplin, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| San Bernardino Urological Associates |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| TOK-001 | Drug | 4 capsules (325 mg each), once per day |
|
|
| TOK-001 | Drug | 6 capsules (325 mg each), once per day |
|
|
| TOK-001 | Drug | 3 capsules (325 mg each), once per day |
|
|
| TOK-001 | Drug | 3 capsules (325 mg each), once per day with supplement |
|
|
| TOK-001 | Drug | 6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner) |
|
|
| TOK-001 | Drug | 8 capsules (325 mg each), once per day |
|
|
| TOK-001 | Drug | 8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner) |
|
|
| San Bernardino |
| California |
| 92404 |
| United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21231 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Comprehensive Cancer Centers of Nevada & US Oncology Research | Las Vegas | Nevada | 89169 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Greenville Hospital System University Medical Center | Greenville | South Carolina | 29605 | United States |
| University of Washington/Seattle Cancer Care Alliance | Seattle | Washington | 98136 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |