MOMENTUM1
Modulation of Metabolic Index in Tailoring Treatment of Incurable Metastatic ColoRectal Cancer (CRC) Program 1.
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
37
1 country
1
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2016
Actual (reported)Study Completion
October 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 25, 2013
Actual (reported)May 1, 2013
Actual (reported)September 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 2016
Actual (reported)October 2016
Actual (reported)To determine the maximum tolerated dose and the recommended phase II dose of capecitabine in association with aflibercept
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.
The time point of the first toxicity evaluation would be the end of the first cycle (3 weeks)
The secondary endpoint is preliminary data on efficacy, and this will be evaluated using CT scan or MRI using RECIST (Response Evaluation Criteria in Solid Tumors) v1.1
after 2 cycles (6 weeks)
capecitabine 1100 to 1600 mg/m2/day orally in association with aflibercept 6mg/kg intravenous every 3 weeks
capecitabine 1700 to 2500 mg/m2/day orally 2 weeks out of 3 and aflibercept 6mg/kg intravenous every 3 weeks
Intravenous 6mg/kg every 3 weeks
Institut Jules Bordet
Brussels, 1000, Belgium
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.
Alain Hendlisz, MD
Jules Bordet Institute
37 participants (actual enrollment reported by the registry).
First Submitted
April 25, 2013
First Posted
May 1, 2013
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome
dose escalation, from 1700 to 2500mg/m2/day 2 weeks out of 3
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 2016
Actual (reported)Study Completion
October 2016
Actual (reported)Last Updated
January 31, 2018
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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