Dose-finding and Pharmacokinetic Trial of Orally Administered D-24851 to Patients With Solid Tumors
- Male or female patient, >= 18 years of age.
- Histologically/cytologically proven solid malignant tumor, for which standard
treatment of proven efficacy are not or no longer available.
- Performance status 0-2 ECOG/WHO.
- Life expectancy > 3 months.
- Able and willing to undergo blood sampling for pharmacokinetics.
- Written informed consent.
- Safety concerns:
- Any non-compensated or uncontrolled non-malignant condition, such as, symptomatic
heart failure, active tuberculosis or any other chronic or active infection.
- History of allergic reaction to one of the ingredients of the trial medication.
- Clinically relevant abnormality in organ function as evidenced by any of the
- White blood cell count: < 3.0 x 109/l ANC: < 1.5 x 109/l
- Thrombocytes: < 100 x 109/l
- Hemoglobin < 6.0 mM
- Bilirubin (total): > 1.5 times upper limit of normal range
- ASAT, ALAT: > 2.5 times upper limit of normal range unless related to metastases in
which case > 5 times upper normal limit is allowed
- Creatinine (serum) > 135 µmol/l (> 1.5 mg/100ml) OR
- Creatinine clearance: < 50 ml/min (calculated according to modified Cockcroft and
- Breast feeding, pregnancy or planned pregnancy. A reliable method of contraception
must be used in men and in women of childbearing potential during the study and for 3
months after last study drug administration.
- Lack of suitability for the trial:
- Concomitant treatment with any other investigational drugs or exposure to another
investigational agent within the last 4 weeks prior to study specific screening
procedures (period should be extended if the patient has received any drug which is
known to have de¬layed toxicity or prolonged half-life).
- Active peptic ulcer or any GI condition that could alter absorption or motility.
- Chronic use of H2-antagonists or proton pump inhibitors.
- Any other cancer treatment during the study or administered within the last 4 weeks
(6 weeks for nitrosoureas, mitomycin C, high-dose carboplatin or extensive
radiotherapy) before start of study treatment, except irradiation of non-target
lesions for symptom relief and bi-phosphonate treatment of bone metastases.
- Clinically symptomatic brain metastases or leptomeningeal disease.
- Neurological or psychiatric disease or drug or alcohol abuse which would interfere
with the patients proper completion of the protocol assignment.
- Administrative reasons:
- Anticipated non-availability for study visits/procedures.