A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases.

ABSTRACT:

Background

Cabozantinib is an oral MET/VEGFR2 inhibitor. A recent phase II study of cabozantinib (100 mg daily) showed improved bone scans in subjects with metastatic castration-resistant prostate cancer (mCRPC), but adverse events (AE) caused frequent dose reductions. This study was designed to determine the efficacy and tolerability of cabozantinib at lower starting doses.

Experimental design

An adaptive design was used to determine the lowest active daily dose among 60, 40, and 20 mg. The primary endpoint was week 6 bone scan response, defined as ≥30% decrease in bone scan lesion area. The secondary endpoint was change in circulating tumor cells (CTC).

Results

Among 11 evaluable subjects enrolled at 40 mg, there were 9 partial responses (PR), 1 complete response, a

SUBMITTER: Lee RJ 

PROVIDER: S-EPMC3684567 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature