drugset / Trial / NCT00719199
Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Open-label phase 1b trial. Study treatment will be administered in 3 week cycles. There are two distinct parts in this study: * Part 1: Dose escalation from IMO-2055 * Part 2: Once a recommended phase 2 dose is found additional tolerability and pharmacodynamics will be explored
Timeline
- Start
- 2009-01
- Primary completion
- 2011-04
- Completion
- 2011-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EMD 1201081 | Oligonucleotide (other) | 0.16 mg/kg | Subcutaneous |
| Subject | EMD 1201081 | Oligonucleotide (other) | 0.32 mg/kg | Subcutaneous |
| Subject | EMD 1201081 | Oligonucleotide (other) | 0.48 mg/kg | Subcutaneous |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Background | Irinotecan | Small molecule | 180 mg/m2 | — |
| Background | Leucovorin | Small molecule | 200 mg/m2 | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |