A Phase I Trial of the Combination of AZD2014 and Weekly Paclitaxel.
Status:
Completed
Trial end date:
2017-11-15
Target enrollment:
Participant gender:
Summary
This is a Phase I study to evaluate the safety and toxicity profile of AZD2014, a novel
anticancer agent, in combination with paclitaxel.
AZD2014 will be given orally, twice daily at a starting dose of 25 mg per day for 3 days on,
4 days off 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 3 days on, 4 days off
schedule of AZD2014, patients will be given AZD2014 2 days on, 5 days 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 2 days on, 5 days off schedule.
On completion of the dose escalation phase of the study patients with ovarian cancer and
squamous cell lung cancer will be treated at the MTD established for each dosing schedule. A
minimum of 10 ovarian cancer patients and 15 squamous cell lung patients will be enrolled to
the 3 days on, 4 days off schedule. Whilst a minimum of 10 squamous cell cancer patients will
be enrolled to the 2 days on, 5 days off schedule to further assess the tolerability of the
combination of AZD2014 and paclitaxel.
Phase:
Phase 1
Details
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Collaborators:
AstraZeneca Institute of Cancer Research, United Kingdom