A Multicentre Randomised Phase II Study of AZD1775 plus Chemotherapy versus Chemotherapy Alone in Patients with Platinum-Resistant TP53-Mutated Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The “investigational drug” AZD1775 is being combined with standard chemotherapy in subjects with TP53-mutated, advanced ovarian, fallopian tube or peritoneum cancer that no longer responds to platinum therapy. AZD1775 is also being studied in lung cancer and ovarian cancer and other solid tumors. Some ovarian cancer patients have experienced tumor shrinkage while receiving AZD1775 plus chemotherapy.
Study phase: II
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
*Must be 18 years of age or older
*Predicted life expectancy of 12 weeks or more
*Histologic or cytologic diagnosis of TP53-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer.
*Progressed within 6 months of completing at least 4 cycles of a first-line platinum-containing regimen, regardless of setting. (Patients with refractory disease are ineligible.)
*No more than 2 prior treatment regimens defined as investigational, chemotherapy, hormonal, biologic, or targeted therapy.
*At least 1 measurable lesion according to RECIST v1.1.
Primary disease category: Cancer
Sponsor: AstraZeneca AB
Protocol number: D6010C00004
Projected enrollment dates: August 2015 to December 2016
Official study title: A Multicentre Randomised Phase II Study of AZD1775 plus Chemotherapy versus Chemotherapy Alone in Patients with Platinum-Resistant TP53-Mutated Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer