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Carolinas HealthCare System

Research and Clinical Trials

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn
The primary objectives are as follows:
 To evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of AGEN1884 in subjects with advanced or metastatic cancer (solid tumors or lymphoma) including but not limited to carcinoma, sarcoma, malignant glioma, or melanoma.
 To determine the maximum tolerated dose (MTD).
 To evaluate the pharmacokinetics (PK) of AGEN1884 in subjects with advanced or
metastatic solid tumors.
Hwang, Jimmy John
The primary objective of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK-positive locally advanced or metastatic NSCLC patients naive to ALK inhibitors, as evidenced by PFS. Carrizosa, Daniel Ricardo
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun
The purpose of this study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with advanced or metastatic tumors. Amin, Asim
To evaluate progression free survival (PFS) with nab-paclitaxel as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin in subjects with squamous cell NSCLC. Mileham, Kathryn Finch
Celgene ABI-007-ST-001 Carrizosa, Daniel Ricardo
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam
The primary objective of this study is to evaluate the safety and tolerability of LY2835219 when administered orally in combination with multiple single-agent options to patients with Stage IV non-small cell lung cancer (NSCLC) using Common Terminology Criteria for Adverse Events (CTCAE version 4.0, NCI 2009). The secondary objectives of the study are to determine the pharmacokinetics (PK) of LY2835219 when given in combination with multiple single-agent options; to document the antitumor activ Kim, Edward Sanghyun
Looking at the safety and efficacy of a once daily inhaled triple medication therapy for patients with COPD. The triple combination will be compared to the current market available dual combiniation therapies. Patients who qualify will be assigned to either the investigational product or one of the dual therapies. They will be followed for 52 weeks and have approximately 7 clinic visits. Patients will be asked to keep a daily diary of their respiratory symptoms on a provided hand-held device. Zgoda, Michael
To assess the response rate of the combination of carboplatin and abraxane in patients with advanced non-small cell lung cancer (NSCLC).
To assess the disease control rate, duration of response, duration of disease control, overall survival, progression-free survival, and the safety and toxicity profile with this regimen.
To assess broad molecular profiling.
Mileham, Kathryn Finch
The primary objectives of this study are to: (1) Identify extrinsic and intrinsic factors and motivators associated with a patient?s decision to initiate or continue maintenance therapy or their decision to decline maintenance therapy;(2) Describe patient perceptions regarding the extent of shared decision making around maintenance therapy; (3) Identify patients? expectations of maintenance therapy; and (4) Identify barriers to maintenance therapy from the patient perspective. Kim, Edward Sanghyun
-To determine the RP2D of LY2606368 and ralimetinib used in combination that may be safely administered to patients with advanced cancer
-Evaluate safety and tolerability of LY2606368 in combination with ralimetinib
Hwang, Jimmy John
Part A Objective:
The primary objective of Part A is to assess the safety and tolerability of ramucirumab when administered in
combination with erlotinib as therapy in previously untreated patients with EGFR mutation-positive metastatic
Part B:
Primary Objectives:
The primary objective of Part B is to compare PFS of ramucirumab administered in combination with erlotinib versus
placebo in combination with erlotinib as therapy in previously untreated patients with EGFR mutation-posit
Mileham, Kathryn Finch
Objectives Endpoints
Phase 1a
and 1b
Primary: To assess the safety and tolerability of ramucirumab in combination with MEDI4736 Dose-limiting toxicities, observed for 1 treatment cycle (21 days for NSCLC and 28 days for Gastric-GEJ and HCC) Safety (including but not limited to):
TEAEs, SAEs, deaths, and clinical laboratory abnormalities per CTCAE (Version 4.0)
Secondary: To assess the PK of ramucirumab and MEDI4736 when co-administered
PK: Cmin and approximate Cmax of ramucirumab and MEDI
Hwang, Jimmy John
This registry is intended to measure the effect of myPlan Lung Cancer? test has on influencing treatment decisions of Oncologists when added to standard clinical-pathological parameters in patients with early stage NSCLC.

Mileham, Kathryn Finch
To evaluate the efficacy of atezolizumab plus carboplatin plus etoposide compared with placebo plus carboplatin plus etoposide in the ITT population as measured by investigator assessed PFS according to RECIST v1.1.

Induru, Raghava Reddy