Personalized treatment of irinoteca

Phase 1

• Conditions: Cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004576-22-NL
• Lead Sponsor: Catharina Hospital Eindhoven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-18
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 388

Inclusion Criteria

1. Pathologically confirmed malignancy for which treatment with irinotecan is indicated at
a dosing regimen of = 180 mg/m2 or 450-600mg flat dose in 2- or 3-weekly treatment schedules (see table 1)
2. Age = 18 years
3. Able and willing to give written informed consent
4. WHO performance status 0-2
5. Minimal acceptable safety laboratory values defined as
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 (eGFR) = 50 ml/min OR creatinine = 1.5 x ULN
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 88

Exclusion Criteria

1. Prior treatment with irinotecan
2. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient’s safety
3. Patients of Asian origin
4. Patients unable or unwilling to stop the use of (over the counter) medication or (herbal) supplements which can interact with irinotecan (e.g. by induction of inhibition of CYP3A4) (see Appendix 2 study protocol).

Study & Design

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