Entry Detail
| General information | |
| Database: | DB00214 |
| Objective: | Systemic therapy options are limited for metastatic castrationresistant prostate cancer (CRPC) patients who progress following docetaxel (Taxotere). Thisphase II trial evaluated sunitinib malate in patients with progressing metastatic CRPC following prior docetaxel. |
| Authors: | Sonpavde G |
| Title: | Sunitinib malate for metastatic castrationresistant prostate cancer following docetaxelbased chemotherapy. |
| Journal: | Ann Oncol |
| Year: | 2010 |
| PMID: | 19633050 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced castrationresistant prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an open label, phase II trial conducted at I0 community cancer centers in the US Oncology Network |
| Key Patients Feature: | Patients with metastatic CRPC progressing following one to two chemotherapy regimens including docetaxel with a median age of 69.5 years |
| Biomarker: | PSA |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | single arm |
| Treatment Info: | Oral sunitinib was administered 50 mg/day 4weeks on follotheyd by 2weeks off per cycle up to a maximum of eight cycles or until clinical progression or intolerable toxicity. |
| Primary End Point: | progression free survival (PFS) per radiographic and clinical evaluations. |
| Secondary End Point: | NA |
| Patients Number: | 36 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Four patients (12.1%) had a > or =50% prostatespecific antigen (PSA) decline and seven (21.2%) had a > or =30% PSA decline. Two of 18 patients (11.1%) with measurable disease demonstrated 30% declines by RECIST and eight (44.4%) displayed some shrinkage. A decline in pain score > or =2 points occurred in 13.6% of 22 assessable patients. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The median PFS was 19.4 weeks with a 12week PFS of 75.8%. |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Drug discontinuation due to toxic effects occurred in 52.8% of patients. |
| Conclusions: | Sunitinib malate demonstrated promising activity in metastatic CRPC progressing after prior docetaxel. |