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A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas

Cancer May 06, 2019

Jones RL, et al. - In this two-part study, researchers assessed ontuxizumab (a humanized monoclonal antibody) in patients with sarcoma. The patients were administered 4, 6, or 8 mg/kg with gemcitabine and docetaxel (G/D; 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8) in part 1, and ontuxizumab (8 mg/kg) or a placebo with G/D was given via randomization in a double-blind fashion in a 2:1 ratio in part 2. In soft-tissue sarcomas, no improved activity of ontuxizumab plus G/D over chemotherapy alone was evident; the combination displayed a safety profile consistent with that of G/D alone.

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