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Modulation of Metabolic Index in Tailoring Treatment of Incurable Metastatic ColoRectal Cancer (CRC) Program 1. (MOMENTUM1)
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.
Details
| Lead sponsor | Jules Bordet Institute |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 37 |
| Start date | 2013-09 |
| Completion | 2016-10 |
Conditions
- Metastatic Colorectal Cancers
- Metastatic Gastric Cancers
- Metastatic Oesophageal Cancers
- Metastatic Pancreatic Cancers
- Metastatic Biliary Cancers
- Metastatic Breast Cancers
Interventions
- capecitabine
- aflibercept
- Capecitabine
Primary outcomes
- To determine the maximum tolerated dose and the recommended phase II dose of capecitabine in association with aflibercept — The time point of the first toxicity evaluation would be the end of the first cycle (3 weeks)
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), the Dose-Limiting Toxicities (DLTs), and to determine the Recommended Phase II Dose (RP2D) of capecitabine in combination with aflibercept.
Countries
Belgium