drugset / Trial / NCT01290926
Sorafenib Plus Capecitabine Efficacy Assessment in Patients With Advanced Pre-treated Colorectal Cancer
Phase 2
Completed
97 enrolled
Jules Bordet Institute
Centre Hospitalier Chretien · collabCliniques universitaires Saint-Luc- Université Catholique de Louvain · collabErasme University Hospital · collabHospital Ambroise Paré Paris · collabINDC Entité Jolimontoise · collabUniversiteit Antwerpen · collab
NaSingle-groupOpen-labelTreatment
Summary
Prospective non-randomized phase II study assessing the activity of the Capecitabine-Sorafenib combination by estimating overall survival of the study population at a fixed time point (6 months) and, as an exploratory analysis the overall survival of metabolic responders versus non-responders.
Timeline
- Start
- 2011-02
- Primary completion
- 2016-01
- Completion
- 2016-01
Publications
- Charette N, Vandeputte C, Ameye L, Bogaert CV, Krygier J, Guiot T, Deleporte A, Delaunoit T, Geboes K, Van Laethem JL, Peeters M, Demolin G, Holbrechts S, Flamen P, Paesmans M, Hendlisz A. Prognostic value of adipose tissue and muscle mass in advanced colorectal cancer: a post hoc analysis of two non-randomized phase II trials. BMC Cancer. 2019 Feb 12;19(1):134. doi: 10.1186/s12885-019-5319-8.
- Hendlisz A, Deleporte A, Delaunoit T, Marechal R, Peeters M, Holbrechts S, Van den Eynde M, Houbiers G, Filleul B, Van Laethem JL, Ceyssens S, Barbuto AM, Lhommel R, Demolin G, Garcia C, El Mansy H, Ameye L, Moreau M, Guiot T, Paesmans M, Piccart M, Flamen P. The Prognostic Significance of Metabolic Response Heterogeneity in Metastatic Colorectal Cancer. PLoS One. 2015 Sep 30;10(9):e0138341. doi: 10.1371/journal.pone.0138341. eCollection 2015.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 850 mg/m2 | Oral |
| Subject | Sorafenib | Small molecule | 400 mg | Oral |