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https://www.selleckchem.com/products/CAL-101.html EORTC-1506-STBSG was a prospective, multicentric, randomised, open-label phase 2 trial to assess the efficacy and safety of second-line nintedanib versus ifosfamide in patients with advanced, inoperable metastatic soft tissue sarcoma (STS). The primary end-point was progression-free survival. Patients with a variety of STS subtypes were randomised 11 to nintedanib (200mgb.i.d. p.o. until disease progression) or ifosfamide (3g/m i.v. days 1-3, every 21 days for ≤6 cycles). A Korn design was applied aiming to detect an improvement in median progression-free survival (mPFS) from 3 to 4.5 months (HR=0.667). An interim look was incorporated to stop the trial for futility if <19 of the first 36 patients treated with nintedanib were progression-free at week 12. At the interim analysis, among the first 36 eligible and evaluable patients randomised for nintedanib, only 13 (36%) were progression-free at week 12. The trial was closed for further accrual as per protocol. In total, 80 patients were randomised (40 per treatment group). The mPFS was 2.5 months (95% CI 1.5-3.4) for nintedanib and 4.4 months (95% CI 2.9-6.7) on ifosfamide (adjusted HR=1.56 [80% CI 1.14-2.13], p=0.070). The median overall survival was 13.7 months (95% CI 9.4-23.4) on nintedanib and 24.1 months (95% CI 10.9-NE) on ifosfamide (adjusted HR=1.65 [95%CI0.89-3.06], p=0.111). The clinical benefit rate for nintedanib and ifosfamide was 50% versus 62.5% (p=0.368), respectively. Common treatment-related adverse events (all grades) were diarrhoea (35.9% of patients), fatigue (25.6%)and nausea (20.5%) for nintedanib; and fatigue (52.6%), nausea (44.7%)and vomiting, anorexiaand alopecia (28.9% each) for ifosfamide. The trial was stopped for futility. The activity of nintedanib did not warrant further exploration in non-selected, advanced STSs. The trial was stopped for futility. The activity of nintedanib did not warrant further exploration in non-selected, advanc

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