Phase
Condition
Stomach Cancer
Gastric Ulcers
Digestive System Neoplasms
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At least 18 years of age.
Histologically confirmed diagnosis of squamous cell cancer or adenocarcinoma,including primary cancer of the liver, of the gastrointestinal tract or cancer ofunknown origin.
Measurable disease according to RECIST 1.1.
Defined time to tumour progression on the standard/experimental treatment precedingthe trial treatment.
Locally advanced or metastatic disease not amenable to standard treatment, i.e.progress on standard therapy or observed/expected intolerance to standard therapy.
- (removed via Amendment 1)
Pharmacological treatment attempt considered reasonable.
Females of childbearing potential should use adequate contraception throughout thestudy;
Combined (estrogen and progestogen containing) hormonal contraception associatedwith inhibition of ovulation (oral, intravaginal or transdermal)
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomized partner
Sexual abstinence
Signed informed consent.
Exclusion
Exclusion Criteria:
Anti-tumour therapy within 3 weeks prior to study drug administration day
Ongoing infection or other major recent or ongoing disease that, according to theinvestigator, poses an unacceptable risk to the patient.
WHO performance status ≥ 2.
Child-Pugh B or C liver function status if hepatocellular carcinoma.
Inadequate laboratory parameters reflecting major organ function i.e.:
neutrophils ≤ 1,3 x 109/l
platelets ≤ 100 x 109/l
bilirubin > 1.5 x upper limit of normal (ULN)
Alanine aminotransferase (ALAT) > 5 x ULN
Glomerular filtration rate (GFR) <50 ml/min (calculated from P-creatinine)
Prothrombin complex/INR outside normal range
Current active participation in any other interventional clinical study.
Contraindications to the investigational product, e.g. known or suspectedhypersensitivity or inability to oral drug administration.
Pregnancy or lactation.
Lack of suitability for participation in the study, e g expected difficulties tofollow the protocol procedures, as judged by the Investigator.
Study Design
Study Description
Connect with a study center
Dept of oncology, University Hospital
Uppsala, 75185
SwedenSite Not Available

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