Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TAK-700-201 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety and tolerability of TAK-700 in patients with asymptomatic metastatic, androgen independent prostate cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (TAK-700) | Experimental |
| |
| Arm 2 (TAK-700 at 400 mg & 5 mg prednisone) | Experimental |
| |
| Arm 3 (TAK-700 at 600 mg & 5 mg prednisone) | Experimental |
| |
| Arm 4 (TAK-700 at 600 mg) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-700 | Drug | Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments:
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of TAK-700 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests. | Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and pharmacokinetics (PSA response and/or objective disease response) | Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Westside Prostate Cancer Center | Beverly Hills | California | United States | |||
| University of Southern California |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Los Angeles |
| California |
| 90048 |
| United States |
| The Angeles Clinic and Research Institute | Los Angeles | California | United States |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | United States |
| South Florida Medical Research | Aventura | Florida | United States |
| Florida Cancer Specialists | Fort Myers | Florida | United States |
| Northwestern University Medical Center | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States |
| University of Chicago Pharmacy | Chicago | Illinois | United States |
| Evanston Hospital | Evanston | Illinois | United States |
| Kellogg Pharmacy - Evanston Hospital | Evanston | Illinois | United States |
| NorthShore University HealthSystem | Evanston | Illinois | United States |
| Kellogg Cancer Care Center | Glenview | Illinois | United States |
| Hematology/Oncology Associates of Central New York | East Syracuse | New York | United States |
| Gabrail Cancer Center | Canton | Ohio | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Taussig Cancer Institute | Cleveland | Ohio | United States |
| Tennessee Oncology | Nashville | Tennessee | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C571806 | orteronel |
Not provided
Not provided
Not provided