Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

May 6, 2019

Study Completion Date

May 6, 2019

Conditions
Solid Tumors
Interventions
DRUG

NC-6004

NC-6004 - given at escalating doses of 60, 75, 90, 105, 120, 135, 150, 165, or 180 mg/m2 according to observations of dose-limiting toxicity.

DRUG

Gemcitabine

Gemcitabine 1250 mg/m2 will be administered as a 30 minute intravenous infusion on Day 1 after the completion of the NC 6004 infusion and on Day 8 of each cycle.

Trial Locations (22)

1632

Multiprofile Hospital for Active Treatment Serdika EOOD, Sofia

9700

Complex Oncology Center - Shumen EOOD, Shumen

20162

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda, Milan

22328

Fundeni Clinical Institute, Bucharest

27599

University of North Carolina at Chapel Hill, Chapel Hill

30171

Coltea Clinical Hospital, Bucharest

31826

Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Krakow

44121

University Hospitals Case Medical Center, Cleveland

47014

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST, Meldola

60611

Northwestern University Feinberg School of Medicine, Chicago

60693

Med-Polonia Sp. z o.o., Poznan

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75390

University of Texas Southwestern Medical Center, Dallas

77030

MD Anderson Cancer Center, Houston

92024

California Cancer Associates for Research and Excellence, Encinitas

92037

UC San Diego Moores Cancer Center, La Jolla

94115

Pacific Hematology Oncology Associates, San Francisco

200347

Oncology Center Sfantul Nectarie, Craiova

400015

Prof Dr I Chiricuta Institute of Oncology, Cluj-Napoca

700106

Euroclinic Oncology Center SRL, Iași

700483

Institutul Regional de Oncologie Iasi, Iași

02111

Tufts Medical Center, Boston

All Listed Sponsors
lead

NanoCarrier Co., Ltd.

INDUSTRY

NCT02240238 - Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer | Biotech Hunter | Biotech Hunter