| General information |
| Database: | DB00222 |
| Objective: | Tasquinimod is a quinoline3carboxamide derivative with antiangiogenic activity. Two openlabelphase I clinical trials in patients were conducted to evaluate the safety and tolerability of tasquinimod, with additional pharmacokinetic and efficacy assessments. |
| Authors: | Bratt O, et al |
| Title: | Openlabel, clinicalphase I studies of tasquinimod in patients with castrationresistant prostate cancer. |
| Journal: | Br J Cancer |
| Year: | 2009 |
| PMID: | 19755981 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | tasquinimod
|
| Target: | Calgranulin B
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | castrationresistant prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Two openlabelphase I clinical trials |
| Key Patients Feature: | Patients with castrationresistant prostate cancer with no previous 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: | The patients received tasquinimod up to 1 year either at fixed doses of 0.5 or 1.0 mg per day or at an initial dose of 0.25 mg per day that escalated to 1.0 mg per day. |
| Primary End Point: | the safety and tolerability |
| Secondary End Point: | pharmacokinetic and efficacy assessments |
| Patients Number: | 32 |
| Trial Results |
| DLT_MTD: | The maximum tolerated dose was determined to be 0.5 mg per day; but when using stepwise intrapatient dose escalation, a dose of 1.0 mg per day was well tolerated. The doselimiting toxicity was sinus tachycardia and asymptomatic elevation in amylase. |
| Objective Response Rate: | A serum prostatespecific antigen (PSA) decline of >or=50% was noted in two patients. |
| Disease Control Rate: | NA |
| Median Time to Progression: | The median time to PSA progression (>25%) was 19 weeks. Only 3 out of 15 patients (median time on study: 34 weeks) developed new bone lesions. |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Common treatmentemergent adverse events included transient laboratory abnormalities, anaemia, nausea, fatigue, myalgia and pain. |
| Conclusions: | Longterm continuous oral administration of tasquinimod seems to be safe, and the overall efficacy results indicate that tasquinimod might delay disease progression. |