WHO ICTRP trial

Phase 0 clinical trial to determine capecitabine exposure in patients that have…

NL-OMON21513 · Overview of Medical Research in the Netherlands (NL-OMON) · Recruiting

Key facts

Trial ID NL-OMON21513
Public title Phase 0 clinical trial to determine capecitabine exposure in patients that have administered a new controlled release tablet of capecitabine, named ModraCape001.
Scientific title Proof of principle and pharmacological phase 0 crossover study with controlled release capecitabine (ModraCape001).
Primary sponsor The Netherlands Cancer Institute
Registry Overview of Medical Research in the Netherlands (NL-OMON)
Recruitment status Recruiting
Study type Interventional
Conditions Patients with cancer who might benefit from treatment with capecitabine, e.g. colon, breast, pancreatic and gastric cancer, ACUP.
Interventions This is a proof of concept and pharmacological phase 0 crossover study whereby the new oral formulation of capecitabine, ModraCape001, will be investigated. The primary endpoint is to determine the pharmacokinetic profile of ModraCape001…
Registration date Oct 3, 2012
Target size 30
Secondary IDs NL3515;NTR3647; : ;ISRCTN wordt niet meer aangevraagd.
Registry page onderzoekmetmensen.nl

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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