Clinical trial · Interventional
Weekly Administration of (bi-)Daily Oral Docetaxel in Combination With Ritonavir
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Oral administration has many advantages above intravenously administrated drugs for patients. Up to now, oral administration of docetaxel as single agent has not been feasible due to low and variable bioavailability. This low systematic exposure to docetaxel can effectively be increased after co-administration of ritonavir. The department of pharmacy of the Slotervaart Hospital and Netherlands Cancer Institute developed a solid oral dosage form for docetaxel, ModraDoc001 10 mg capsules. Two other novel dosage forms of docetaxel with improved pharmaceutical characteristics, have been developed: ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets. The systemic exposure after administration of those forms is now being investigated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ModraDoc001 10mg capsules | Drug | — | UNRESOLVED |
| ModraDoc003 10mg tablets and ModraDoc004 10/50 mg | Drug | — | UNRESOLVED |
| ModraDoc006 10 mg tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ModraDoc001 10 mg capsules
- description
- The optimal dose weekly bi-daily oral docetaxel - ModraDoc001 10 mg in combination with ritonavir will be determined with a classical dose escalation design. Approximately 24 patients will be enrolled depending on required number of dose levels before MTD is reached.
- interventionNames
- Drug: ModraDoc001 10mg capsules
- type
- EXPERIMENTAL
- label
- ModraDoc003 10mg tablets and ModraDoc004 10/50 mg
- description
- Both new oral dosage forms, ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets will be investigated to see whether these new formulations have comparable pharmacokinetic characteristics, in terms of systemic exposure to docetaxel, as ModraDoc001 10 mg capsule.
- interventionNames
- Drug: ModraDoc003 10mg tablets and ModraDoc004 10/50 mg
- type
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Histological or cytological proof of cancer 2. Patients for whom no standard therapy of proven benefit exist 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 allowing adequate follow up of toxicity evaluation and anti-tumor activity 8. Minimal acceptable safety laboratory values * ANC of \_ 1.5 x 109 /L * Platelet count of \_ 100 x 109 /L * Hepatic function as defined by serum bilirubin \_ 1.5 x ULN, ALAT and ASAT \_ 2.5 x ULN * Renal function as defined by serum creatinine \_ 1.5 x ULN or creatinine clearance \_ 50 ml/min (by Cockcroft-Gault formula). 9. WHO performance status of \_ 2 10. No radio- or chemotherapy within the last 4 weeks prior to study entry (palliative limited radiation 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 history that are not suitable for adequate follow up 2. Women who are pregnant or breast feeding. 3. Both men and women enrolled in this trial must 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). 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 analoga, St. Johns wort or macrolide antibiotics as erythromycin and clarithromycin. 5. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients 6. Unresolved (\>grade 1) toxicities of previous chemotherapy 7. Bowel obstructions or motility disorders that may influence the absorption of drugs 8. Chronic use of H2-receptor antagonists or proton pump inhibitors 9. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity 10. Pre-existing neuropathy greater than CTC grade 1 11. Symptomatic cerebral or leptomeningeal metastases 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.
References
Publications (1)
- DERIVEDVermunt MAC, van der Heijden LT, Hendrikx JJMA, Schinkel AH, de Weger VA, van der Putten E, van Triest B, Bergman AM, Beijnen JH. Pharmacokinetics of docetaxel and ritonavir after oral administration of ModraDoc006/r in patients with prostate cancer versus patients with other advanced solid tumours. Cancer Chemother Pharmacol. 2021 Jun;87(6):855-869. doi: 10.1007/s00280-021-04259-5. Epub 2021 Mar 20. PMID 33744986