drugset / Trial / NCT01163903
Pantoprazole With Doxorubicin for Advanced Cancer Patients With Extension Cohort of Patients With Solid Tumours
Phase 1
Completed
24 enrolled
University Health Network, Toronto
Princess Margaret Hospital, Canada · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single-centre, open label, dose finding, phase I study to determine the recommended phase II dose (RP2D) for the combination of doxorubicin and pantoprazole in patients with advanced tumours and no standard treatment options. A minimum of 3 patients will be enrolled per dose level and intra-patient dose escalation is not permitted. Once the RP2D has been identified, six additional patients with metastatic solid tumours will be treated at the RP2D to confirm its tolerability.
Timeline
- Start
- 2010-07
- Primary completion
- 2014-03
- Completion
- 2015-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pantoprazole | Other / unclassified | 80 mg | Intravenous |
| Subject | Pantoprazole | Other / unclassified | 160 mg | Intravenous |
| Subject | Pantoprazole | Other / unclassified | 240 mg | Intravenous |
| Subject | Pantoprazole | Other / unclassified | 320 mg | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |