drugset / Trial / NCT01454089
A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm.
Timeline
- Start
- 2011-10
- Primary completion
- 2014-11
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apatorsen | Antisense oligonucleotide | 600 mg | Intravenous |
| Subject | Apatorsen | Antisense oligonucleotide | 1000 mg | Intravenous |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |