Trials / Completed
CompletedNCT00545545
Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
A Phase 1b, Safety, PK, and Efficacy, Multicenter, Dose-Escalating Study of Imprime PGG in Combination With Cetuximab With and Without Irinotecan Therapy in Patients With Recurrent/Progressive Colorectal Carcinoma Following Treatment With a 5-FU Regimen.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- HiberCell, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Imprime PGG 2 mg/kg | Infusion of 2mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops. |
| BIOLOGICAL | Imprime PGG 4 mg/kg | Infusion of 4mg/kg on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops. |
| BIOLOGICAL | Cetuximab | Infusion 400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle; |
| DRUG | Irinotecan | Infusion 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| BIOLOGICAL | Imprime PGG 6mg/kg | Infusion of 6mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops. |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2007-10-17
- Last updated
- 2025-03-19
- Results posted
- 2025-03-19
Locations
2 sites across 1 country: Philippines
Source: ClinicalTrials.gov record NCT00545545. Inclusion in this directory is not an endorsement.