Carolinas HealthCare System

Research and Clinical Trials

Brief Description Principal Investigator
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 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 evaluate the individual and collective associations between biological (biomarkers) and clinical characteristics of the lung adenocarcinoma tumour at the time of diagnosis and disease progression on first-line platinum-doublet chemotherapy. 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
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
To evaluate the clinical efficacy of atezolizumab 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
The primary objective of this study is to investigate the concordance of Inivata liquid biopsy panel with standard tissue biopsy analysis for detecting genomic alterations in patients with advanced non-small cell lung cancer (NSCLC). Mileham, Kathryn Finch
To determine the one-year progression-free survival rate, progression-free survival, overall survival, and toxicity of subjects with locally-advanced non-small cell lung cancer treated with stereotactic body radiation therapy followed by concurrent mediastinal chemoradiation with either proton therapy or photon therapy.
Heinzerling, John Henry
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
NSCLC.
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
HVLT-R delayed recall deterioration status, defined using the Reliable Change Index (RCI) (Phase III)

Intracranial relapse rate (Phase II)
Heinzerling, John Henry
- To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors
- To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Brown, Jubilee
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