A study about adjusting the dose of the anticancer drugs fluoropyrimindes based on mutations in DNA (genetic code)

Phase 1

• Conditions: Types of cancer for which capecitabine and 5-fluorouracil are authorized, this includes colorectal cancer, gastric cancer and locally advanced or metastatic breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005064-15-NL
• Lead Sponsor: etherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-ALV)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-18
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

1.Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient’s best interest
2.Age ? 18 years
3.Able and willing to give written informed consent
4.WHO performance status of 0, 1 or 2
5.Life expectancy of at least 12 weeks
6.Able to swallow and retain oral medication
7.Able and willing to undergo blood sampling for pharmacogenetic and phenotyping analysis
8.Minimal acceptable safety laboratory values
a.ANC of ? 1.5 x 109 /L
b.Platelet count of ? 100 x 109 /L
c.Hepatic function as defined by serum bilirubin ? 1.5 x ULN, ALAT and ASAT ? 2.5 x ULN; in case of liver metastases ALAT and ASAT ? 5 x ULN.
d.Renal function as defined by serum creatinine ? 1.5 x ULN or creatinine clearance ? 60 ml/min (by Cockcroft-Gault formula).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 650
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

1.Prior treatment with fluoropyrimidines
2.Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient’s safety
3.Women who are pregnant or breast feeding
4.Both men and women who refuse to use reliable contraceptive methods throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms)
5. Patients with a homozygous polymorphic genotype or compound heterozygous genotype for DPYD.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified