Trials / Withdrawn
WithdrawnNCT03688230
Study of Abituzumab in Combination With Cetuximab and FOLFIRI in Patients With Metastatic Colorectal Cancer.
AMELION: A Randomized, Double Blinded, Phase 2, Efficacy and Safety Study of Abituzumab (EMD 525797) in Combination With Cetuximab and FOLFIRI Versus Placebo in Combination With Cetuximab and FOLFIRI in First-line RAS Wild-type, Left-sided, Metastatic Colorectal Cancer Patients With High ανβ6 Integrin Expression.
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- SFJ Pharmaceuticals X, LTD. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of the experimental drug abituzumab (EMD525797) in combination with cetuximab and FOLFIRI in RAS wild-type, left-sided, metastatic colorectal cancer patients with high ανβ6 integrin expression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | abituzumab | 1000 mg IV |
| COMBINATION_PRODUCT | Placebo + Cetuximab + FOLFIRI | 400 mg/m2 over 120 min followed by 250 mg/m2 weekly 60 min or 500 mg/m2 every two weeks, initially 120 min followed by 60 to 90 min |
Timeline
- Start date
- 2019-04-01
- Primary completion
- 2020-12-01
- Completion
- 2021-08-01
- First posted
- 2018-09-28
- Last updated
- 2020-03-18
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03688230. Inclusion in this directory is not an endorsement.