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 weekly paclitaxel. 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 weekly paclitaxel.
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.
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.
Arm B: Arm B (AZD1775 + paclitaxel) will enroll approximately 30 additional patients at selected sites as part of a further efficacy evaluation based on emerging data that suggests clinical activity.
Arm C2: Initially, 6 patients will be enrolled to receive 5 doses of AZD1775 in approx. 12 hour intervals over the first 2.5 days of Weeks 1, 2, and 3 (i.e., Days 1-3, 8-10, and 15-17) of each 28 day cycle. If 1 patient or less experiences a DLT during Cycle 1, then 6 more patients will be enrolled for a total of 12. However, if 2 or more of the first 6 patients experience a DLT then the AZD1775 dosing may be modified to 2 weeks on followed by 1 week off. All patients will receive carboplatin on Day 1 of each 28 day cycle. AZD1775 should be taken approximately 2 hours before or 2 hours after food. 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.
Enrollment in Arms A and C is complete. Enrollment will not continue in Arm D.
Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Paclitaxel Albumin-Bound Paclitaxel Carboplatin
For females ages 18–130
Predicted life expectancy ≥ 12 weeks
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