drugset / Trial / NCT02240238
Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-05
- Primary completion
- 2019-05-06
- Completion
- 2019-05-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NC-6004 | Other / unclassified | 60 mg/m2 | — |
| Subject | NC-6004 | Other / unclassified | 75 mg/m2 | — |
| Subject | NC-6004 | Other / unclassified | 90 mg/m2 | — |
| Subject | NC-6004 | Other / unclassified | 105 mg/m2 | — |
| Subject | NC-6004 | Other / unclassified | 120 mg/m2 | — |
| Subject | NC-6004 | Other / unclassified | 135 mg/m2 | — |
| Subject | NC-6004 | Other / unclassified | 150 mg/m2 | — |
| Subject | NC-6004 | Other / unclassified | 165 mg/m2 | — |
| Subject | NC-6004 | Other / unclassified | 180 mg/m2 | — |
| Background | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |