drugset / Trial / NCT02151357
Safety, Tolerability and Pharmacokinetics of DCBCI0901 in Patients With Advanced Solid Tumor
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DCBCI0901 | Unknown | 7.5 mg/m2 | Intravenous |