lung cancer Non-small cell lung cancer
Conditions
Interventions
Patients will receive ModraDoc tablet/ritonavir bi-daily weekly. Venipunction.
On dag 1 and 8, when kinetics will be done, a venflon will be used for all
bloodsamples during 24 hours.
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Histological or cytological proof of stage IV NSCLC. 2.Patients who did not experience disease progression after four cycles of first line standard platinum doublet chemotherapy (not including a taxane). 3.Registered and start within six weeks after the last platinum-combination therapy administration. 4.Age of 18 years or older. 5.Able and willing to give written informed consent. 6.Minimal acceptable safety laboratory values.;a. Hb *6.0 mmol/L;b. ANC of * 1.5 x 109 /L ;c. Platelet count of * 100 x 109 /L;d. Hepatic function as defined by serum bilirubin * 1.5 x ULN, ALAT and ASAT * 2.5 x ULN (5 X ULN if liver metastases are present). ;e. Renal function as defined by serum creatinine * 1.5 x ULN or creatinine clearance * 50 ml/min (by Cockcroft-Gault formula).;7. WHO performance status of 0 or 1.;8. Able and willing to swallow oral medication.
Exclusion criteria
Exclusion criteria: 1.Prior adjuvant or neo-adjuvant chemotherapy for NSCLC. 2.Previous treatment with a taxane. 3.Patients with suspected or known brain metastases. 4.Patients with known alcoholism, drug addiction, psychotic disorders in their history and/or other reasons, for which they are not amenable for adequate follow up. 5.Women who are pregnant or breast-feeding. 6.Both men and women enrolled in this trial who do not agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms). 7.Concomitant use of MDR and CYP3A modulating drugs and agents such as Ca¬¬+-entry blockers (verapamil, dihydropyridines), cyclosporine, (non) nucleoside analogs, St. Johns worth, macrolide antibiotics as erythromycin and clarithromycin, quinidine, quinine, tamoxifen, megestrol, concomitant use of HIV medication or other protease inhibitors, grapefruit juice (see for an extended list appendix VI).;8. Chronic use of corticosteroids corresponding to a dose of >10 mg prednisone. ;9. Unresolved (> grade 1) toxicities of previous chemotherapy, excluding alopecia.;10. Bowel obstructions or motility disorders that may influence the absorption of the study drug.;11. Pre-existing neuropathy greater than NCI-CTCAE v4.03 grade 1.;12. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * To determine the DLT and the MTD/RP2D of docetaxel as ModraDoc006/ritonavir that can be administered safely to patients with NSCLC in a bi-daily weekly schedule, following platinum doublet first-line treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| * To determine the systemic exposure of the bi-daily ModraDoc006 in combination with ritonavir in patients with NSCLC after platinum-doublet therapy. * To preliminary assess anti-tumor activity of ModraDoc006/ritonavir in patients with NSCLC. * To establish the effect of functional genetic polymorphisms in five genes (SLCO1B3, ABCB1, ABCC2, CYP3A4 and CYP3A5) on the pharmacokinetics of oral docetaxel and ritonavir. | — |
Countries
Netherlands
Outcome results
None listed