Global Observational Study to Evaluate the Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links with Clinical Outcomes
Observational study to collect F/U imaging & clinical endpoint data from pts. who successfully completed baseline coronary IVUS (intravascular ultrasound) imaging in the dal-PLAQUE 2 (DP2) study to determine the correlation & clinical relevance of such imaging as related to coronary artery disease (CAD). Pts. who have had baseline angiography/IVUS, with or w/o baseline carotid ultrasound but NOT undergone follow-up angiography/IVUS as part of DP2 will have F/U angiogram/IVUS within 18-27 mos. of baseline imaging. Pts. who have had baseline carotid ultrasound but NOT undergone a F/U carotid ultrasound as part of DP2 will have follow-up carotid ultrasound within 18-27 mos. of baseline imaging. Main objectives is to compare: extent of atherosclerosis in coronary arteries with the extent of atherosclerosis in carotid arteries at a single point in time. Pts. who have successfully undergone baseline IVUS imaging, with or w/o baseline carotid ultrasound, in DP2 will be included. Pts., who successfully completed baseline angiography/IVUS in DP2, with or w/o baseline carotid ultrasound, will be scheduled for final F/U angiography/IVUS any time between 18-27 mos. after DP2 baseline imaging. Pts. who successfully completed baseline carotid ultrasound in DP2 will be scheduled for F/U carotid ultrasound any time between 18 -27 mos. after DP2 baseline imaging. Endpoints: death, death from coronary heart disease, resuscitated cardiac arrest, non-fatal MI, stroke, hospitalization for documented acute coronary syndrome, coronary revascularization procedure & carotid artery surgery or angioplasty. Pts. will have annual phone contact for 3 yrs. to check for the occurrence of cardiovascular & cerebrovascular clinical endpoints. Imaging parameters from this study will be combined with the imaging data from DP2 to compare coronary & carotid atherosclerosis extent at baseline & rate of progression up to 2 yrs.
0C-14-7: A Phase 1/2A, Multicenter, Open-Label Study of Oral RxDx-101 in Adult Patients with Locally Advanced or Metastatic Cancer Confirmed to be Positive for TRKA, TRKB, TRKC, ROS1, or ALK Molecular Alterations
RXDX-101-01 is a multicenter, open-label, Phase 1/2a study in which the safety and efficacy of RXDX-101 will be evaluated in adult patients with any locally advanced or metastatic solid tumor.
The primary objective of the Phase 2a expansion cohorts is Objective Response (OR) defined as Complete Response(CR) and Partial Response (PR) at the recommended phase 2 dose of RXDX-101.
RXDX-101 is an orally available inhibitor of the tyrosine kinases TrkA, TrkB, TrkC, ROS1, and ALK. Molecular alterations to these targets are present in several different tumor types, including non-small cell lung cancer, colorectal cancer, papillary thyroid cancer, pancreatic cancer, and neuroblastoma.
The Phase 2a segment of this study will consist of 5 cohorts as described below:
Cohort #1: Participants that express TrkA. Cohort #2: Participants that express TrkB. Cohort #3: Participants that express TrkC. Cohort #4a: Participants that express ALK with an associated molecular alteration who are nave to prior treatment with ALK inhibitors. Cohort #4b: Participants that express ALK with an associated molecular alteration who have received prior treatment with one or more ALK inhibitors. Cohort #5: Participants that express ROS1
USC will only participate in Phase 2 of the study. The length of participation is about 2 months
An End of Treatment Visit will be conducted within 7 days of last dose of RXDX-101.
A Safety Follow-Up telephone call will be conducted approximately 30 days following the last dose of RXDX-101.
Primary endpoint will be first cycle dose limiting toxicities and maximum tolerated dose
The baseline, clinical outcome, laboratory, PK, and safety data from both segments of the study will be analyzed descriptively
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.
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).
2N-13-2: A Randomized, Phase 3 Study of Ganetespib in Combination with Docetaxel versus Docetaxel Alone in Patients with Advanced Non-Small-Cell Lung Adenocarcinoma
This is an open-label, multicenter, randomized Phase 3 study of patients with Stage IIIB/IV NSCLC of adenocarcinoma histology.Primary Objective is to evaluate and compare overall survival (OS) in non-small cell lung cancer (NSCLC) patients with adenocarcinoma histology treated with ganetespib in combination with docetaxel versus docetaxel alone.Ganetespib is a novel synthetic small molecule that binds to the adenosine triphosphate (ATP) pocket in the N-terminus of Hsp90 and demonstrates significant activity for down-regulating Hsp90 client protein levels. This ability to impact a broad array of important oncogenes and cell signaling kinases is reflected in ganetespibs activity across a wide variety of tumor cell types.Patients will be randomized in a 1:1 ratio to receive either ganetespib in combination with docetaxel or docetaxel alone. The study will enroll approximately 500 patients, 12 from USC, over a planned 12-month period, and patients will be randomized into one of two treatment arms.
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
This study is complementary to a multi-center, randomized, double-blind,parallel-group,
placebo-controlled, variable treatment duration study comparing the efficacy and safety of
BAF312 to placebo in patients with SPMS (NCT01665144). Investigators will explore both
immunological and neuroprotective mechanisms of BAF312 (siponimod), a novel agent in the
setting of a SPMS clinical trial.
This study is part of a multi-center study, with the University of Michigan serving as the
central site.
A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma
This is an open label, multi-center, single arm phase II study. The study will investigate
the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of
patients with recurrent or persistent PrR-negative endometrial cancer.
Eligible patients will be enrolled into the study and administered sodium cridanimod in
combination progestin therapy. Objective responses will be assessed at 12 week intervals.
Patients will be treated for a 12 month period, followed by an additional 12 month follow up
period or to disease progression whichever occurs first.
Important objectives of the study are to investigate the effect of sodium cridanimod in
conjunction with progestin therapy on the level of PrR in tumor tissue and how this
correlates to efficacy. To accomplish this objective, some of the patients enrolled in the
study will undergo two tumor biopsies that will allow measurement of PrR levels in the tumor
tissue before the treatment and after 4 weeks of therapy.
Medtronic CoreValve® U.S. Expanded Use Study
The primary objective of the study is to evaluate the safety and effectiveness of the
Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme
Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a
composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic
severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled
in this study have a predicted operative mortality or serious, irreversible morbidity risk
of ≥50% at 30 days associated with surgical aortic valve replacement.
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