A Phase I trial of AZD2014 in combination with paclitaxel

• Research type

  Research Study

• Full title

  TAX-TORC: A Phase I multi-centre trial of the combination of AZD2014 (dual TORC1 and TORC2 inhibitor) and weekly paclitaxel in patients with solid tumours

• IRAS ID

  80223

• Contact name

  Udai Banerji

• Sponsor organisation

  The Royal Marsden NHS Foundation Trust

• Eudract number

  2012-003896-20

• ISRCTN Number

  xx

• Research summary

  This is a Phase I study to evaluate the safety and toxicity profile of AZD2014, a novel anti-cancer agent, in combination with paclitaxel.AZD2014 will be given orally, twice daily at a starting dose of 25 mg per day for 3 days each week (Intermittent Schedule) with a weekly infusion of 80 mg of paclitaxel for 6 weeks followed by a treatment break of one week, therefore each cycle will be 7 weeks long. Cohorts of three patients will be treated at this dose of AZD2014 and then at 50mg and 75 mg providing is it safe to do so. Once we have determined the maximum tolerated dose (MTD) using the Intermittent Schedule of AZD2014, patients will be given AZD2014 once per week (Once weekly Schedule) at that dose with their paclitaxel infusion. Patients will be enrolled in cohorts of three to evaluate three escalating doses of AZD2014 to determine the MTD for the Once Weekly Schedule. On completion of the dose escalation phase of the study patients with platinum-resistant ovarian cancer will be treated at the MTD established for each dosing schedule. A minimum of 10 patients will be enrolled to each schedule to further assess the tolerability of the combination of AZD2014 and paclitaxel.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  13/LO/0066

• Date of REC Opinion

  14 Feb 2013

• REC opinion

  Favourable Opinion