drugset / Trial / NCT02151357

Safety, Tolerability and Pharmacokinetics of DCBCI0901 in Patients With Advanced Solid Tumor

NCT02151357 ↗

Phase 1 Terminated 17 enrolled Standard Chem. & Pharm. Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

* Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with advanced solid tumor * Pharmacokinetic parameters will be calculated for DCBCI0901, if data permit. * Anti tumor activity: The efficacy endpoint will be the overall response rate (ORR) defined as the proportion of patients who continuously receive treatment after Cycle 1 with a best overall response of complete response (CR) or partial response (PR).

Timeline

Start
2014-08-19
Primary completion
2016-06-24
Completion
2016-10-31

Outcome

Outcome not reported

Stopped: “catheter occlusion events during the study drug infusion”

Drugs

EvaluationDrugModalityDoseRoute
Subject DCBCI0901 Unknown 7.5 mg/m2 Intravenous

Indications