Solid Tumors
Conditions
Brief summary
Dose-finding and pharmacokinetic trial of orally administered Indibulin to patients with solid tumors.
Interventions
DRUGindibulin
Dose escalation, daily dosing for 14 days every 3 weeks, for up to 4 months
Sponsors
Alaunos Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 following pa¬ra¬meters: * 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 Gault) * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| toxicities | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics | 4 months |
Countries
Netherlands
Outcome results
None listed