Topotarget has announces positive data from a phase Ib/II study with belinostat and 5-fluorouracil, 5-FU. These are used for patients with colorectal cancer. The study has established that belinostat and 5-FU can be safely given together in full doses. So far, 35 previously heavily treated patients with progressed solid tumors, whereof most suffered from colorectal cancer, have been treated. Of these heavily treated patients 9, 26 per cent, obtained stabilisation of their disease.
synergy between belinostat and 5-FU and this clinical study supports this assumption in patients’ blood and cancer tissue. The Phase Ib portion of this study was aiming to find the MTD of intravenous administered belinostat in combination with 5-FU in patients with progressed solid tumors for whom there is no standard treatment. An extensive central evaluated investigation of BelFU’s effect on the heart was performed and no cardiac side effects were seen.
study was that the BelFU combination should be further evaluated, preferably in patients with less extensive prior treatment, including further assessments of the potential for patient selection based on a favourable expression pattern for TS, DPD, and p21.
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