Assessing brain response to sugar
This study is aimed at understanding brain and hunger responses to different types of sugars and how this influences feeding behavior in lean and obese people.
Spectroscopic detection of colon polyps (Spy Colonic Neoplasia)
The purpose of this study is to determine if colon cancer or precancerous colon polyps can be predicted from examining the lining of the rectum with a special harmless light. If so, primary care physicians will be able to determine from this simple test which of their patients actually needs a colonoscopy instead of referring 100% of their patients simply because they turn 50 years old.
7H-14-1 An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Head and neck carcinomas (HNC) describe cancers of the upper digestive tract which include squamous cell cancers (SCCHN) of the mouth, throat, and vocal chords. At present, there is no effective standard of care that provides survival benefits beyond 4 - 6 months in second line treatment of SCCHN that spreads or returns and does not respond to platinum treatment (refractory). Nivolumab is a drug that binds to a tumor cell receptor that blocks the immune system, thus allowing the immune system to attack tumor cells. Nivolumab has demonstrated clinical activity across several tumor types, but there has been no clinical trial so far to study the clinical benefit of nivolumab in SCCHN. Cetuximab, methotrexate, and docetaxel, which appear to be the most active in the platinum refractory setting, have approved indications as single agents for treating SCCHN and will be used as the Investigator's Choice in this study. The objective of this study is to compare progression free survival (PFS) and overall survival (OS) of Nivolumab to Investigators Choice in subjects who have tumor progression within 6 months of last dose of platinum therapy.
Patients who will be enrolled for this study will have laboratory confirmed SCCHN whose disease has spread or returned within 6 months of being treated with a platinum based therapy. Participants will be randomized to receive one of the following: nivolumab, cetuximab, methotrexate, or docetaxel. During the study, participants in all groups will have the study procedures done during each cycle as stated in the protocol. All participants will stop taking study drug(s) if their disease worsens, they have another illness which prevents them from taking the study drug(s), they cannot tolerate the side effects, they withdraw from the study, their study doctor thinks that being on the study is no longer in their best interest, or the sponsor stops the study. All participants will be followed for 35 days and 80 days after stopping the study drug(s), and then every 3 months until death.
Subject characteristics including demographics, baseline performance status, disease
characteristics and baseline laboratory parameters will be summarized by randomized treatment
arm, as well as pooled across randomized treatment arm. A two-sided 0.03 log-rank test will be used to do a formal comparison of PFS across all treatment arms. Median PFS will be estimated via the Kaplan-Meier product limit method. Two-sided 95% confidence intervals (CI) for the median PFS will be computed for each randomized arm. Kaplan-Meier plots of PFS will be presented. Hazard ratios (HR) and corresponding two-sided (1-adjusted )% CI will be estimated using a Cox proportional hazards model, with treatment arm as a single covariate, stratified by the above factor, corresponding to each comparison of PFS. OS will be compared between the treatment arms among all randomized subjects using a two sided, = 0.02 level log-rank test (adjusted for interim analysis), stratified using the same factor as in PFS.
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).
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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