Phase 0 clinical trial to determine capecitabine exposure in patients that have administered a new controlled release tablet of capecitabine, named ModraCape001.
Recruiting
- Conditions
- Patients with cancer who might benefit from treatment with capecitabine, e.g. colon, breast, pancreatic and gastric cancer, ACUP.
- Registration Number
- NL-OMON21513
- Lead Sponsor
- The Netherlands Cancer Institute
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Histological or cytological proof of cancer;
2. Patient who might benefit from treatment with capecitabine, e.g. colon, breast, pancreatic and gastric cancer, ACUP;
Exclusion Criteria
1. Dihydropyrimidine dehydrogenase (DPD) deficiency as assessed on the basis of DPYD mutation analysis;
2. Women who are pregnant or breast feeding;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the plasma pharmacokinetics of capecitabine after intake of different<br>formulations of ModraCape and after intake of Xeloda®.
- Secondary Outcome Measures
Name Time Method 1. To determine the plasma AUC of capecitabine and its metabolites 5-dFCR, 5-dFUR and<br>5-FU after administration of different ModraCape formulations and Xeloda;<br /><br>2. To determine the intracellular pharmacokinetics of 5-FU nucleotides after administration<br>of different formulations of ModraCape or Xeloda;<br /><br>3. To determine dihydropyrimidine dehydrogenase (DPD) enzyme activity in peripheral<br>blood mononuclear cells (PBMCs);<br /><br>4. To determine thymidylate synthase (TS) enzyme activity in peripheral blood<br>mononuclear cells (PBMCs);<br /><br>5. To determine the preliminary safety and tolerability profile of different formulations of<br>ModraCape.