| General information |
| Database: | DB00247 |
| 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: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | castrationresistant prostate cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | RAD001+ bicalutamide |
| Study Type: | an openlabel, singlearmphase II trial |
| Key Patients Feature: | men with progressive CRPC 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 |
| Biomarker: | PSA |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | single arm |
| Treatment Info: | RAD001 (10 mg daily) in combination with bicalutamide (50 mg daily).This singlestage trial with a sample size of 38 eligible patients provided 90% potheyr to differentiate a response rate of more than and equal to 40% from a response rate of less than and equal to 20%, as expected for bicalutamide alone (¦Á= 0.10, potheyr = 0.90). |
| Primary End Point: | 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: | Stable disease and progressive disease were observed in nine (25%) and 20 (36%) patients, respectively. however, all cases with stable disease lasted <6 months. |
| 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. |