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Clinical Trial
.2009 Oct 20;101(8):1233-40.
doi: 10.1038/sj.bjc.6605322. Epub 2009 Sep 15.

Open-label, clinical phase I studies of tasquinimod in patients with castration-resistant prostate cancer

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Clinical Trial

Open-label, clinical phase I studies of tasquinimod in patients with castration-resistant prostate cancer

O Bratt et al. Br J Cancer..

Abstract

Background: Tasquinimod is a quinoline-3-carboxamide derivative with anti-angiogenic activity. Two open-label phase I clinical trials in patients were conducted to evaluate the safety and tolerability of tasquinimod, with additional pharmacokinetic and efficacy assessments.

Methods: Patients with castration-resistant prostate cancer with no previous chemotherapy were enrolled in this study. 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.

Results: A total of 32 patients were enrolled; 21 patients were maintained for >or=4 months. The maximum tolerated dose was determined to be 0.5 mg per day; but when using stepwise intra-patient dose escalation, a dose of 1.0 mg per day was well tolerated. The dose-limiting toxicity was sinus tachycardia and asymptomatic elevation in amylase. Common treatment-emergent adverse events included transient laboratory abnormalities, anaemia, nausea, fatigue, myalgia and pain. A serum prostate-specific antigen (PSA) decline of >or=50% was noted in two patients. 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.

Conclusion: Long-term continuous oral administration of tasquinimod seems to be safe, and the overall efficacy results indicate that tasquinimod might delay disease progression.

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Figures

Figure 1
Figure 1
Study design of study I and study II.
Figure 2
Figure 2
Waterfall plot of best PSA response per subject, with each bar representing one patient's lowest percentage decline after treatment initiation (n=28). The 28 patients are divided into three groups (M0, M1, and MX) according to distant metastasis on bone scan at baseline.
Figure 3
Figure 3
Kaplan–Meier graph of time to PSA progression (PSA increase >25% over baseline or on-treatment NADIR) in patients entering the extension phase (n=23; censored subjects=circle). The median PSA PFS was 19 weeks.
Figure 4
Figure 4
Kaplan–Meier graph of time to new bone lesions in patients treated at a fixed dose of 0.5 mg per day (n=15; censored subjects=circle).
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