| General information |
| Database: | DB00233 |
| Objective: | To determine best overall response and duration of response of RAD001, a selective inhibitor of mammalian target of rapamycin, in combination with bicalutamide in castrationresistant prostate cancer (CRPC). To characterize the toxicity profile of RAD001 in combination with bicalutamide in patients with CRPC |
| Authors: | Nakabayashi M, et al |
| Title: | Phase II trial of RAD001 and bicalutamide for castrationresistant prostate cancer. |
| Journal: | BJU Int |
| Year: | 2012 |
| PMID: | 22928480 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | everolimus
|
| Target: | mammalian target of rapamycin (mTOR)
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | castrationresistant prostate cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | RAD001+ bicalutamide |
| Study Type: | a phase II study |
| Key Patients Feature: | men with progressive CRPC; pts with a median (range) age of 68 (6072) years and median (range) baseline PSA level of 22.2 (8.4121.3) ng/mL, and 89% had metastatic disease. There were 31 (86%) patients had previously used bicalutamide for a median duration of 7.4 months. |
| Biomarker: | Serum prostatespecific antigen |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | RAD001 (10 mg daily) in combination with bicalutamide (50 mg daily) in men with progressive CRPC |
| Primary End Point: | a composite of prostatespecific antigen (PSA) level and measurable disease response by standard criteria |
| Secondary End Point: | NA |
| Patients Number: | 36 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | There were two patients with a confirmed PSA level decline more than and equal to 50%. |
| Disease Control Rate: | NA |
| Median Time to Progression: | The median (interquartile range) time to progression was 8.7 (7.915.9) weeks |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common toxicity was grade 1/2 mucositis, which was observed in 20 (56%) patients. |
| Conclusions: | The combination of RAD001 and bicalutamide in men with CRPC was well tolerated but had low activity and failed to achieve the primary endpoint of improved response compared to the results previously achieved for bicalutamide alone in this population. |