Carolinas HealthCare System

Research and Clinical Trials


Brief Description Principal Investigator
The primary objective of this trial is to establish statistical equivalence in terms of efficacy (overall response rate (ORR), proportion of patients with Complete Response (CR) plus Partial Response (PR) until 18 weeks of first-line treatemnt with BI 695502 plus chemotherapy versus Avastin plus chmeotherapy, followed by maintenance therapy. Kim, Edward Sanghyun 
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 
To assess the safety and tolerability of weekly continous nab-paclitaxel (Abraxane┬«) vs. with 1 week break in combination with Carboplatin as 1st line treatment for advanced NSCLC in elderly subjects >70 years old). Haggstrom, Daniel Ernest 
Celgene ABI-007-ST-001 Carrizosa, Daniel Ricardo 
Phase I: To determine the safety and tolerability, DLTs, MAD or MTD and RP2D of the combination of rociletinib and trametinib when administered to patients with locally advanced or metastatic activating EGFR mutation-positive (EGFRm) NSCLC. To assess the PK profile of rociletinib and trametinib when given in combination.
Phase II: To determine the efficacy of the combination of rociletinib and trametinib based on ORR (CR or PR) per RECIST v1.1 in the following advanced or metastatic EGFRm NSCLC
Mileham, Kathryn Finch 
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 assess the safety and tolerability of the combination of PEGPH20 with docetaxel (PDoc).
To determine the recommended Phase 2 dose (RP2D) of PDoc.
To determine the recommended Phase 2 schedule of PDoc in subjects whose tumors have high levels of HA (high-HA).
Haggstrom, Daniel Ernest 
Primary Objectives to include: PrimaryTo determine safe and biologically active Phase 2 doses (recommended Phase 2 doses [RP2D]) for JNJ-42756493 in the Part 1 Dose-Escalation Phase; and to evaluate the feasibility of treating a molecularly-defined subset of subjects with non-small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), breast cancer, and all-comers with solid tumors with JNJ-42756493 at the RP2Ds (Part 3 and 4; Dose-Expansion Phases).
Secondary Objectives to include: To evalu
Chai, Seungjean 
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 
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 assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with
INC280 in patients with cMET positive NSCLC patients
Mileham, Kathryn Finch 
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