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| ID | Type | Description | Link |
|---|---|---|---|
| SMART |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial.
Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib (SU011248) | Drug | SU011248 (study medication) will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2 week rest period to form a complete cycle of 6 weeks. Study medication will be orally self administered once daily without regard to meals beginning on Day 1 of the study. Cycles will be repeated in the absence of unacceptable toxicity or disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 180 days without evidence of disease progression would be considered clinically worthy of further investigation |
| Measure | Description | Time Frame |
|---|---|---|
| -PSA Response -Toxicity | The secondary endpoint of PSA response will also be documented. PSA response is defined as a ≥50% fall in PSA (minimum of 5 µg/L) from baseline maintained for > 3 weeks and without evidence of disease progression otherwise. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard Eigl, M.D. | Tom Baker Cancer Board | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre | Calgary | Alberta | t4c 2h5 | Canada | ||
| Cross Cancer Institute |
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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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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Edmonton |
| Alberta |
| T6G 1Z2 |
| Canada |
| Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |