TCD11379 - Phase I study of Ombrabulin in advanced solid tumours

• Research type

  Research Study

• Full title

  An open-label, non-randomised, dose escalation, safety and pharmacokinetic phase I study of ombrabulin (AVE8062) in combination with bevacizumab administered by intravenous infusion every 3 weeks in patients with advanced solid tumours.

• IRAS ID

  54677

• Contact name

  Rhoda Molife

• Eudract number

  2009-017797-20

• ISRCTN Number

  N/A

• Research summary

  TCD11379 is a phase I study of an experimental drug (ombrabulin)in combination with a drug already commercially available (bevacizumab, Avastin©) in patients with advanced cancers. Ombrabulin is a vascular disrupting agent (VDA) as well as in inhibitor of tubulin polymerization in cells including endothelial cells (cells that make up blood vessels). It causes shutdown of tumor blood vessels and stops adhesion of endothelial cells. Bevacizumab inhibits the formation of new tumour vasculature, thereby slowing tumour growth. The use of ombrabulin with bevacizumab in combination in this study is supported by the complementary activities of these 2 compounds on the tumor blood supply. The expected effect on the tumor would be to obtain additive/synergistic effects of each drug and particularly on the formation of new vessels in the tumour leading to tumor necrosis (death). The purpose of this study is to establish the Maximum Administered Dose (MAD) and Maximum Tolerated Dose (MTD) of ombrabulin in combination with the best tolerated dose of bevacizumab. Other objectives are to:- assess the overall safety profile - characterise the pharmacokinetics of both drugs - assess preliminary anti-cancer activity of the combination - assess the pharmacodynamic effects - evaluate predictive markers Patients who have been fully informed of the study, have provide written informed consent and are eligible for the study will be treated at escalating doses of drugs in cohorts of 3 patients. This study will be conducted in a cancer centre under the care of oncologists with a specialist interest in Phase I trials.

• REC name

  London - Central Research Ethics Committee

• REC reference

  10/H0718/56

• Date of REC Opinion

  8 Oct 2010

• REC opinion

  Further Information Favourable Opinion