a study on Peritoneal Cancer
A Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Patients will receive AZD1775 plus carboplatin or AZD1775 plus pegylated liposomal doxorubicin (PLD). The primary study objective is to evaluate the objective response rate (ORR).
A Multicentre Phase II Study of AZD1775 Plus Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This is a phase II study of AZD1775 plus chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients will receive AZD1775 plus carboplatin or AZD1775 plus pegylated liposomal doxorubicin (PLD). The primary endpoint for the study is overall response rate (ORR) defined as the proportion of patients achieving a complete or partial tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. Secondary endpoints include assessment of the duration of response (DoR), overall survival (OS), progression-free survival (PFS), disease control rate (DCR), Gynecologic Cancer Intergroup (GCIG) cancer antigen-125 response, safety and tolerability, clinically significant changes in safety-related laboratory parameters, pharmacokinetics (PK) and drug-drug interactions of AZD1775 plus carboplatin and AZD1775 plus PLD.
Six (6) patients will be enrolled in the AZD1775 plus carboplatin arm (designated Arm C) in a dose escalation scheme as a safety lead-in cohort. When a safe and tolerable dose of AZD1775 in combination with carboplatin is determined, 17 additional patients will be enrolled to be treated at that dose level. Patients may continue on study as long as they are benefitting, have no evidence of disease progression, and do not meet any criteria for discontinuation or withdrawal.
Up to 12 patients will be enrolled in the AZD1775 plus PLD arm (designated Arm D) in a dose escalation scheme as a safety lead-in cohort. Dose expansion will not be conducted in Arm D. Patients may continue on study as long as they are benefitting, have no evidence of disease progression, and do not meet any criteria for discontinuation or withdrawal.
A Safety Review Team (SRT) will assess the safety and tolerability of the first 6 patients in each arm by incidence and severity of adverse events (AEs) after a minimum of 1 treatment cycle as determined by NCI CTCAE v4.03 and the occurrence of pre-defined dose-limiting toxicities (DLTs). Patients must complete Cycle 1 safety evaluations, and return to the study centre for Cycle 2 Day 1 evaluations to be considered evaluable for the safety lead-in.
Following a positive safety assessment for the AZD1775 plus carboplatin arm (Arm C) by the SRT, Arm C will continue enrolling until 23 patients have been evaluated for efficacy (i.e., tumour response). Enrollment will not continue in Arm D.
Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Carboplatin
For females ages 18 years to 130 years
Predicted life expectancy ≥ 12 weeks
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