Phase 0 clinical trial to determine capecitabine exposure in patients that have administered a new controlled release tablet of capecitabine, named ModraCape001.

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;

3. Age: 18 years or older;

4. WHO performance status of 0, 1 or 2;

5. Able and willing to give written informed consent;

6. Able and willing to undergo blood sample collection for pharmacokinetic (PK) measurements and biomarker analysis;

7. ife expectancy is at least 3 months allowing adequate follow up;

8. Minimal acceptable safety laboratory values:

A. ANC of at least 1.5 x 109 /L;

B. Platelet count of at least 100 x 109 /L;

C. Hemoglobin of at least 6.5 mmol/L;

D. Hepatic function as defined by serum bilirubin not higher than 1.5 x ULN,
ALAT and ASAT not higher than 3.0 x ULN (not higher than 5 x ULN in case of liver metastases);

E. Renal function as defined by serum creatinine not higher than 1.5 x ULN or creatinine clearance at least 50 ml/min (by Cockcroft-Gault formula).

9. No radio- or chemotherapy within 3 weeks of receiving first dose of study medication (palliative limited radiation of 1 x 8 Gy for pain reduction is allowed);

10. Able and willing to swallow oral medication;

11. Negative pregnancy test (urine/serum) for female patients with childbearing potential.

1. Dihydropyrimidine dehydrogenase (DPD) deficiency as assessed on the basis of DPYD mutation analysis;

2. Women who are pregnant or breast feeding;

3. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms);

4. Bowel obstructions or motility disorders that may influence the absorption of drugs;

5. Pre-existing neuropathy > grade 1;

6. Unresolved (> grade 1) toxicities (except alopecia) of previous chemotherapy;

7. Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up;

8. The use of any drug or complementary alternative medicine that might interfere with the biotransformation of capecitabine and/or 5FU, like CYP2C9 substrates with narrow therapeutic windows (e.g., vitamin K antagonizing anticoagulants [acenocoumarol, phenprocoumon, warfarin], phenytoin), allopurinol, folic acid, folinic acid, interferon alpha, metronidazol, sorivudine (and analogues), aluminium hydroxide and magnesium hydroxide;

9. Current participation or previous participation in a study with an investigational compound, or chemo- and/or radiotherapy within 21 days of receiving first dose of study medication. (Palliative limited radiation of 1 x 8 Gy for pain reduction is allowed);

10. Prior stem cell or bone marrow transplant;

11. Known hypersensitivity to the components of the study drug or its analogs;

12. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;

13. Patients with a known history of hepatitis B or C;

14. Symptomatic cerebral or leptomeningeal metastases;

15. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity;

16. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.