A Randomised Placebo-controlled Trial of Saracatinib (AZD0530) Plus Weekly Paclitaxel in Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
A multicentre, randomised, double-blind, placebo-controlled Phase II trial will be
conducted. The overall aim of the trial is to investigate whether the addition of
saracatinib to weekly paclitaxel improves efficacy, as measured by progression free
survival, compared with paclitaxel plus placebo. The trial will also determine toxicity and
ascertain whether the combination of paclitaxel plus saracatinib should proceed to a phase
The toxicity data from Study D8180C00015 suggests that a small number of patients could
experience febrile neutropaenia during their first chemotherapy cycle. To combat this,
saracatinib (175 mg OD)/matched placebo will begin 1 week prior to commencement of
chemotherapy, and be given continuously until progression.
All patients will receive cycles of weekly paclitaxel chemotherapy. One cycle will consist
of weekly paclitaxel (80 mg/m2) for 6 weeks followed by 2 weeks rest. If there is evidence
of on-going response after 4 cycles, 3 further cycles of saracatinib/placebo plus weekly
paclitaxel will be given, unless there is dose-limiting toxicity or the patient requests to
discontinue treatment. If best response is stable disease after 4 cycles, treatment should
be discontinued but may continue at the discretion of the Investigator.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
6 month progression-free survival rate (based on combined RECIST v1.1/GCIG CA125 criteria)
Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria alone. The 6 month progression-free survival rate will be calculated by the trial statistician during the final analysis.
Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.
Barts and the London NHS Trust
United Kingdom: Medicines and Healthcare products Regulatory Agency (executive agency of the UK Department of Health)