Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung Cancer
Conditions
Solid Tumors
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: NC-6004 Type: Drug
Name: Gemcitabine Type: Drug
Overall Status
Recruiting
Summary
This study will determine the maximum tolerated dose (MTD) of NC 6004 in combination with gemcitabine and evaluate the activity, safety, and tolerability of NC- 6004 in combination with gemcitabine in patients with advanced solid tumors and second- or third line squamous and nonsquamous Stage IIIB/IV NSCLC.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- (Part 1 only) Have a histologically or cytologically confirmed diagnosis of advanced solid tumor that has relapsed or is refractory to standard curative or palliative therapy or has a contraindication to standard therapy.

- (Part 2 only) Have histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC and have received 1 or 2 lines of prior chemotherapy or targeted therapy for Stage IIIB or IV NSCLC (second- or third-line).

- Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Have adequate bone marrow reserve, liver function, and renal function

Exclusion Criteria:

- Have received prior platinum therapy in the past 3 months

- Have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.

- Unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment

- Pregnant or breast feeding
Locations
UC San Diego Moores Cancer Center
La Jolla, California, United States
Status: Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Status: Recruiting
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Status: Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
May 2014
Completion Date
September 2015
Sponsors
Nanocarrier Co., Ltd.
Source
Nanocarrier Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page