In the dose escalation phase (Part 1), this study will determine the dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of NC 6004 in combination with gemcitabine. In the expansion phase of the study (Part 2), study will evaluate the activity, safety, and tolerability at the RPII dose identified in Part 1 in patients with squamous NSCLC, biliary tract, and bladder cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
119
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.
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.
California Cancer Associates for Research and Excellence
Encinitas, California, United States
Determine the RPII Dose of NC-6004 in Combination With Gemcitabine
In the dose-escalation phase of the study (Part 1), to determine the dose-limiting toxicities (DLTs), MTD, and RPII dose of NC-6004 in combination with gemcitabine
Time frame: 1 year
Activity of NC-6004 Measured by Progression-free Survival (PFS)
In the expansion phase of the study (Part 2), to evaluate the activity of NC-6004 in combination with gemcitabine in patients with first-line Stage IV squamous NSCLC, first-line advanced or metastatic biliary tract cancer, and first-line metastatic or locally advanced bladder cancer compared with historical control as measured by local investigator/radiologist-assessed progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: 1 year
ORR
To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS
Time frame: Up to 40 weeks
DCR
To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS
Time frame: Up to 40 weeks
DOR
To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS
Time frame: every 6 weeks tumor assessments for response and disease progression after treatment discontinuation and telephone calls for survival every 12 weeks until disease progression.
OS
To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS
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UC San Diego Moores Cancer Center
La Jolla, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
...and 12 more locations
Time frame: every 6 weeks tumor assessments for response and disease progression after treatment discontinuation and telephone calls for survival every 12 weeks until disease progression.
EORTC QLQ-C30
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) has the 5 functional scales (physical, role, emotional, cognitive, social), and 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). All of the scales and single item measures range in score from 0 to 100. A positive value of change from baseline means a better outcome in functional scales and a worse outcome in symptom scales.
Time frame: 1 year