| General information |
| Database: | DB00253 |
| Objective: | Prostate cancer cells undergo neuroendocrine differentiation during androgen deprivation and secrete neuropeptides, hence activating androgen receptorregulated genes. Srcfamily protein kinases are involved in neuropeptideinduced prostate cancer growth and migration. a phase II trial of AZD0530, an oral Srcfamily kinase inhibitor, in patients with advanced castration resistant prostate cancer was conducted. |
| Authors: | Lara PN Jr, et al |
| Title: | a phase II trial of the Srckinase inhibitor AZD0530 in patients with advanced castrationresistant prostate cancer: a California Cancer Consortium study. |
| Journal: | Anticancer Drugs. |
| Year: | 2009 |
| PMID: | 19396016 |
| Trial Design |
| Clinical Trial Id: | NCT00513071 |
| Agent: | AZD0530
|
| Target: | Protooncogene tyrosineprotein kinase SRC, Abl
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced castrationresistant prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II trial |
| Key Patients Feature: | patients with advanced castrationresistant prostate cancer; Eligibility criteria included documentation of castration resistance (including antiandrogen withdrawal), adequate endorgan function, and performance status, and not more than one prior taxanebased chemotherapy regimen; Median age was 67 years. Sixteen patients had performance status (PS) 0, eight patients had PS 1, and four patients had PS 2. Nine patients (32%) had prior docetaxelbased chemotherapy. |
| Biomarker: | PSA |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | single arm |
| Treatment Info: | AZD0530 was given at 175 mg orally once daily continuously. |
| Primary End Point: | prostate cancerspecific antigen (PSA) response rate, defined as a 30% or greater decrease. |
| Secondary End Point: | NA |
| Patients Number: | 28 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Five patients had transient PSA reductions not meeting PSA response criteria. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 8 weeks |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Treatment was generally well tolerated. |
| Conclusions: | AZD0530, a potent oral Src kinase inhibitor, is feasible and tolerable in this pretreated patient population but possessed little clinical efficacy as monotherapy. Strong preclinical evidence warrants further investigation of AZD0530 in earlierstage prostate cancer or as combination therapy. |