Food Effect Study of ModraDoc006 in Combination With Ritonavir

• Status: Completed
• Trial end date: 2018-04-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Modra Pharmaceuticals
• Collaborator: The Netherlands Cancer Institute
• Treatments: Docetaxel; Ritonavir

Criteria

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