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

NCT01843725 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-01-31

No results posted yet for this study

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.

Conditions

  • Metastatic Colorectal Cancers
  • Metastatic Gastric Cancers
  • Metastatic Oesophageal Cancers
  • Metastatic Pancreatic Cancers
  • Metastatic Biliary Cancers
  • Metastatic Breast Cancers

Interventions

DRUG

capecitabine

escalation dose of capecitabine continuously

DRUG

aflibercept

Intravenous 6mg/kg every 3 weeks

DRUG

Capecitabine

dose escalation, from 1700 to 2500mg/m2/day 2 weeks out of 3

Sponsors & Collaborators

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Alain Hendlisz, MD · Jules Bordet Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01843725 on ClinicalTrials.gov