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. When a safe and tolerable dose of AZD1775 in
combination with PLD 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.
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.
Once the AZD1775 plus carboplatin (Arm C) and AZD1775 plus PLD (Arm D) arms are evaluated as
safe and tolerated by the SRT, these arms will continue enrolling until 23 patients have
been evaluated for efficacy (i.e., tumour response).
Assessing the Efficacy of Secukinumab in Psoriasis Patients
The purpose of the study is to see if secukinumab has an effect on fatty tissue beneath the skin and on skin inflammation in patients with psoriasis. This study will also look at blood tests, or “markers,” that could help identify risk for heart disease and metabolic diseases like diabetes or cardiometabolic disease. Secukinumab (Cosentyx®) is a prescription medicine that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis in adults.
Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be
enrolled at up to 35 centers in the US. After re-placement of their aortic heart valve with
the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the
following intervals: discharge, 3 months, 1 year, and annually the-reafter for a minimum of
five years.
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