| General information |
| Database: | DB00489 |
| Objective: | Thisphase 1b study was designed to further evaluate the safety and efficacy of everolimus in VEGFrTKIrefractory Chinese patients with mRCC. |
| Authors: | Guo J, et al |
| Title: | Safety and efficacy of everolimus in Chinese patients with metastatic renal cell carcinoma resistant to vascular endothelial growth factor receptortyrosine kinase inhibitor therapy: an openlabelphase 1b study. |
| Journal: | BMC Cancer. |
| Year: | 2013 |
| PMID: | 23514360 |
| Trial Design |
| Clinical Trial Id: | NCT01152801 |
| Agent: | everolimus
|
| Target: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | clear cell renal carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | openlabel, multicenterphase Ib study |
| Key Patients Feature: | Adult Chinese patients with mRCC who were intolerantto or who progressed while still on or after stoppingtreatment with VEGFrTKI therapy within 6 monthswere enrolled (N = 64). Patients were required to haveconfirmed clear cell mRCC with at least 1 measurablelesion (RECIST, version 1.0), a Karnofsky PerformanceStatus (KPS) more than and equal to 70%, and adequate bone marrow, liver, and renal function. Patients with brain metastases wereeligible if were neurologically stable and did not require corticosteroids |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received everolimus 10 mg daily until objective tumor progression (according to RECIST, version 1.0), unacceptable toxicity, death, or study discontinuation for any other reason. |
| Primary End Point: | safety and tolerability. |
| Secondary End Point: | disease control rate, overall response rate, PFS, and overall survival (OS). |
| Patients Number: | 64 |
| Trial Results |
| DLT_MTD: | Expected known classeffect toxicities related to mTOR inhibitor therapy were observed, including anemia (64%), hypertriglyceridemia (55%), mouth ulceration (53%), hyperglycemia (52%), hypercholesterolemia (50%), and pulmonary events (31%). Common grade 3/4 adverse events were anemia (20%), hyperglycemia (13%), increased gammaglutamyltransferase (11%), hyponatremia (8%), dyspnea (8%), hypertriglyceridemia (6%), and lymphopenia (6%). |
| Objective Response Rate: | The overall tumor response rate was 5% (95% CI, 113%). The majority of patients (61%) had stable disease as their best overall tumor response. |
| Disease Control Rate: | 0.61 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.9 months (95% CI, 3.712.5 months) |
| Median OS A vs. C: | NR(not reached) |
| Adverse Event(agent arm): | Expected known classeffect toxicities related to mTOR inhibitor therapy were observed, including anemia (64%), hypertriglyceridemia (55%), mouth ulceration (53%), hyperglycemia (52%), hypercholesterolemia (50%), and pulmonary events (31%). Common grade 3/4 adverse events were anemia (20%), hyperglycemia (13%), increased gammaglutamyltransferase (11%), hyponatremia (8%), dyspnea (8%), hypertriglyceridemia (6%), and lymphopenia (6%). |
| Conclusions: | Safety and efficacy results were comparable to those of the RECORD1 trial. Everolimus is generally well tolerated and provides clinical benefit to Chinese patients with antiVEGFrefractory mRCC. |