Phase 1 Study Testing the Combination of Aflibercept and Capecitabine in Metastatic Digestive and Breast Cancers

Phase 1 Completed 37 enrolled Jules Bordet Institute

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Prospective non randomized, non-comparative, dose escalation, two arms open phase I trial to assess the safety and tolerability of capecitabine given in combination with aflibercept in patients with measurable or evaluable, chemorefractory digestive tumors or breast tumors in terms of the Maximum Tolerated Dose (MTD) and the Dose-Limiting Toxicities (DLTs), To establish the Recommended Phase II Dose (RP2D) of capecitabine in combination with Aflibercept.

Timeline

Start: 2013-09
Primary completion: 2016-10
Completion: 2016-10

Publications

Camera S, Deleporte A, Bregni G, Trevisi E, Pretta A, Telli TA, Polastro L, Gombos A, Kayumba A, Ameye L, Piccart-Gebhart M, Awada A, Sclafani F, Hendlisz A. MOMENTUM: A Phase I Trial Investigating 2 Schedules of Capecitabine With Aflibercept in Patients With Gastrointestinal and Breast Cancer. Clin Colorectal Cancer. 2020 Dec;19(4):311-318.e1. doi: 10.1016/j.clcc.2020.05.007. Epub 2020 May 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aflibercept	Protein / enzyme biologic	6 mg/kg	Intravenous
Subject	Capecitabine	Small molecule	1100 mg/m2	Oral
Subject	Capecitabine	Small molecule	1300 mg/m2	Oral
Subject	Capecitabine	Small molecule	1600 mg/m2	Oral
Subject	Capecitabine	Small molecule	1700 mg/m2	Oral
Subject	Capecitabine	Small molecule	2500 mg/m2	Oral

Phase 1 Study Testing the Combination of Aflibercept and Capecitabine in Metastatic Digestive and Breast Cancers

Summary

Timeline

Publications

Drugs

Indications