| General information |
| Database: | DB00223 |
| Objective: | The activity of the novel antitumor agent tasquinimod (TASQ) with S100A9 as a molecular target was investigated in men with metastatic castrationresistant prostate cancer (CRPC) and minimal symptoms. |
| Authors: | Pili R, et al |
| Title: | Phase II randomized, doubleblind, placebocontrolled study of tasquinimod in men with minimally symptomatic metastatic castrateresistant prostate cancer. |
| Journal: | J Clin Oncol |
| Year: | 2011 |
| PMID: | 21931019 |
| Trial Design |
| Clinical Trial Id: | NCT00560482 |
| Agent: | tasquinimod
|
| Target: | Calgranulin B
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | minimally symptomatic metastatic castrateresistant prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a randomized, doubleblind, placebocontrolledphase II trial |
| Key Patients Feature: | men with minimally symptomatic metastatic castrateresistant prostate cancer |
| Biomarker: | PSA |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | placebo |
| Treatment Info: | patients were assigned (at a ratio of two to one) to either oral oncedaily TASQ 0.25 mg/d escalating to 1.0 mg/d over 4 weeks or placebo. |
| Primary End Point: | the proportion of patients without disease progression at 6 months, or pain criteria, excluding prostatespecific antigen. |
| Secondary End Point: | NA |
| Patients Number: | 201 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Sixmonth progression free proportions for TASQ and placebo groups were 69% and 37%, respectively (P < .001), and median progression free survival (PFS) was 7.6 versus 3.3 months (P = .0042). In PCWG2 CRPC clinical subgroups, PFS in months was as follows: nodal metastases, 6.1 versus 3.1; bone metastases, 8.8 versus 3.4; and visceral metastases, 6.0 versus 3.0 for patients receiving TASQ versus placebo, respectively. |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Adverse events (AEs) occurring more frequently in the TASQ arm included GI disorders, fatigue, musculoskeletal pains, and elevations of pancreatic and inflammatory biomarkers. Grade 3 to 4 AEs, including asymptomatic elevations of laboratory parameters, were reported in 40% of patients receiving TASQ versus 10% receiving placebo; deep vein thrombosis (4% v 0%) was more common in the TASQ arm. |
| Conclusions: | TASQ significantly slotheyd progression and improved PFS in patients with metastatic CRPC with an acceptable AE profile. |