Solid Tumor, Adult Clinical Trial
Official title:
Food-effect Study of Weekly Administration of (bi-)Daily Oral Docetaxel (ModraDoc006) in Combination With Ritonavir
NCT number | NCT03147378 |
Other study ID # | N15FED |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 10, 2017 |
Est. completion date | April 4, 2018 |
Verified date | October 2021 |
Source | Modra Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the effect of food on the pharmacokinetics of ModraDoc006 in combination with ritonavir, in an open-label, cross-over design. Patients will be randomized into two treatment groups receiving ModraDoc006/r week 1 under fasting and week 2 under fed condition, or vice versa.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 4, 2018 |
Est. primary completion date | April 4, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histological or cytological proof of cancer 2. Patients for whom no standard therapy of proven benefit exists 3. Patients who might benefit from treatment with docetaxel, e.g. advanced breast, gastric, esophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancers, prostate cancer and carcinoma of unknown primary site. 4. Age 18 years 5. Able and willing to give written informed consent 6. Able and willing to undergo blood sampling for pharmacokinetics 7. Life expectancy 3 months 8. Minimal acceptable safety laboratory values 8.1. Hb = 6.0 mmol/l 8.2. ANC 1.5 x 109 /L 8.3. Platelet count 100 x 109 /L 8.4. Serum bilirubin 1.5 x ULN, ALAT and ASAT 2.5 x ULN (or 5 x ULN in case of presence of liver metastases) 8.5. Serum creatinine 1.5 x ULN or creatinine clearance 50 ml/min (by Cockcroft-Gault formula). 9. WHO performance status of 1 10. No radio- or chemotherapy within the last 4 weeks prior to first dose of study medication (palliative radiation on limited field for pain reduction is allowed) 11. Able and willing to swallow oral medication. Exclusion Criteria: 1. Patients with known alcoholism, drug addiction and/or psychotic disorders in the medical history that are not suitable for adequate follow up 2. Women who are pregnant or breast-feeding. 3. Men and women, who do not agree to use two reliable contraceptive methods hroughout the study (adequate contraceptive methods are: use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom, diaphragm with spermicide, male sterilization, true abstinence). 4. Concomitant use of MDR and CYP3A modulating drugs such as Ca+-entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications; other protease inhibitors, (non) nucleoside analogs, St. Johns wort or macrolide antibiotics like erythromycin and clarithromycin. 5. Uncontrolled infectious disease or known HIV-1 or HIV-2 infection 6. Unresolved (>grade 1) toxicities of previous chemotherapy, excluding alopecia 7. Bowel obstructions or motility disorders or previous surgery that may influence the absorption of drugs 8. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity 9. Pre-existing neuropathy greater than CTC grade 1 10. Patients with suspected or known brain metastases, unless they have been adequately treated and are asymptomatic without use of corticosteroids (for at least 1 month) 11. 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. 12. Legal incapacity |
Country | Name | City | State |
---|---|---|---|
Netherlands | Netherlands Cancer Institute - Antoni van Leeuwenhoek | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Modra Pharmaceuticals | The Netherlands Cancer Institute |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The AUC of docetaxel (area under the curve) | The AUC of docetaxel given as bi-daily ModraDoc006 10 mg tablets in combination with ritonavir after administration in a high fed and fasting condition | Pharmacokinetic sampling during 2 weeks, 0-48 hours after administration (i.e. the 2 treatment cycles) | |
Primary | The cMax (peak concentration) of docetaxel | The cMax (peak concentration) of docetaxel given as bi-daily ModraDoc006 10 mg tablets in combination with ritonavir after administration in a high fed and fasting condition | Pharmacokinetic sampling during 2 weeks, 0-48 hours after administration (i.e. the 2 treatment cycles) | |
Secondary | The hematological and non-hematological toxicity profile of oral docetaxel in combination with ritonavir | The number of CTCAE v.4.03 grade 3-4 toxicities during treatment with ModraDoc006/r | Safety and tolerance will be evaluated during the complete study treatment untill 28 days after the last intake, using the CTCAEv4.03 grading system | |
Secondary | The effect of functional genetic polymorphisms on the pharmacokinetics of oral docetaxel and ritonavir (to understand the mechanism of the drug-drug interaction more thoroughly) | Pharmacogenetic analyses will be performed for polymorphisms in drug metabolizing enzymes (e.g., but not limited to genes encoding for P-glycoprotein (ABCB1/MDR1), Multidrug resistance protein 2 (ABCC2/MRP2), Organic anion-transporting polypeptides 1B3 (OATP1B3), Cytochrome P450 (CYP) 3A4 and CYP3A5) | Sampling at baseline, the analyses will be performed retrospectively |
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