Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of Oral Tablet of Irinotecan in Adult Patients With Solid Tumors
Lead Sponsor:
Dorte Nielsen
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study evaluates the safety, tolerability and pharmacokinetics of oral administration of irinotecan in adult patients. Oral irinotecan will be administered as monotherapy in a dose escalation tria...
Detailed Description
The study is a phase I, open-label, dose escalation single center study in patients with solid tumors. The study will investigate safety, tolerability and Maximal Tolerated Dose as primary end-points ...
Eligibility Criteria
Inclusion
- Signed written Informed Consent
- 18 years of age or older
- Capable of understanding the protocol requirements and risk associated with the study
- Patients must have histological confirmed malignancy (solid tumor) that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- Patients with either measurable disease according to RECIST 1.1 or non-measurable disease
- Performance status 0-1 (ECOG)
- Life expectancy ≥ 3 months
- Coagulation INR \< 1.3 and APTT within normal limits
- WBC ≥ 3000/mm3
- Absolute neutrophil count ≥ 1500/mm3
- Hemoglobin ≥ 6.0 mmol/L
- Platelet count ≥ 100.000/mm3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN AST and ALT ≤ 2.5 times ULN. For patients with liver metastasis adequate hepatic function is defined by aspartate aminotransferase (AST) ≤ 5 x ULN and alanine aminotransferase ALT ≤ 5 x ULN
- No severe or uncontrolled renal condition (creatinine ≤ than 1.5 ULN)
- No significant cardiovascular disease (New York Heart Association Class III and IV)
- No other severe cardiac condition not defined above
- No significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year prior for patients to be enrolled and treated in combination with oral capecitabine
- No severe or uncontrolled pulmonary condition
- No known prior hypersensitivity reaction to irinotecan
- No known prior hypersensitivity to capecitabine or 5-fluorouracil for patients to be enrolled and treated in combination with oral capecitabine
- No chronic enteropathy (e.g. active inflammatory bowel disease, extensive intestinal resection or chronic diarrhea)
- No bowel obstruction or sub-obstruction
- No prior history of intestinal malabsorption
- Patients have to be able to swallow normally and have to be willing to comply with the intake of tablets
- No psychiatric condition that would preclude study participation
- No co-existing active infection requiring antibiotics or any co-existing medical conditions likely to interfere with study procedures
- No other condition that will preclude study participation
- A negative pregnancy test for women of childbearing potential. For men and women of child-producing potential, the use of effective contraceptives methods during the study and at least 3 months after discontinuations of the study drug is required.
- Not pregnant or nursing
- Peripheral neuropathy NCI CTCAE grade less than 2 for patients to be enrolled and treated in combination with oral capecitabine
- The patient is willing and able to comply with hospitalization for treatment and scheduled follow-up visits and examinations
Exclusion
- Simultaneous participation in any other study involving investigational drugs or having participated in a study within 4 weeks prior to start of study treatment
- Symptomatic brain metastases
- Intake of any prohibited concomitant medication
- Known Dihydropyrimidine dehydrogenase (DPD) deficiency for patients to be enrolled and treated in combination with oral capecitabine.
Key Trial Info
Start Date :
July 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03295084
Start Date
July 15 2015
End Date
October 30 2018
Last Update
October 5 2020
Active Locations (1)
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1
Herlev Hospital
Herlev, Denmark, 2730