20 November, 2018
Single-use technology, designed for the manufacturing of biopharmaceutical products, has made major inroads over the last 30 years. First introduced in the late 1970s in the form of disposable capsules and a ...
ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma (NCT02343406)
This study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide versus temozolomide or lomustine alone in participants with recurrent glioblastoma multiforme.
This trial is sponsored by AbbVie. 
Initial results from an unrelated phase I study to evaluate the safety, pharmacokinetics, and the maximum tolerated dose (MTD) of ABT-414 when administered every 14 days with concurrent radiotherapy and temozolomide in newly diagnosed GBM patients, presented at the 2014 European Society of Medical Oncology (ESMO) Annual Congress, September 26-30, in Madrid, Spain, show that pharmacokinetics and safety data are supported a dose of 2.4 mg/kg as the predicted maximum tolerated dose. Preliminary safety data further demonstrate increased liver and eye toxicities in addition to common toxicities of radiotherapy and temozolomide. Based on these initial results, the researchers conclude that further follow-up may demonstrate whether ABT-414 improves outcome. The initial analysis of data was based on the data from 22 treated patients (13 male/9 female median age 58 years, range 34-79). 
Last Editorial review: August 26, 2017
Information based on Clinicaltrials.gov (NIH/NCI) and other sources.
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20 November, 2018
05 October, 2018
When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000, only a handful of patent applications claiming ADCs had been published. As research cont...