Mass balance of docetaxel after administration of Oral Docetaxel in combination with Ritonavir

Completed

• Conditions: cancer; malignancy; 10027655

• Registration Number: NL-OMON35601
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1. Histological or cytological proof of cancer
2. Patient 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 cancer, prostate cancer and carcinoma of unknown primary site.
4. Age GE 18 years
5. Able and willing to give written informed consent
6. Able and willing to undergo blood sampling for pharmacokinetics
7. Able and willing to comply with the study protocol for the duration of the study
8. Life expectancy GE 3 months allowing adequate follow up of toxicity evaluation and antitumor activity
9. Minimal acceptable safety laboratory values
a. ANC of GE 1.5 x 10^9 /L
b. Platelet count of GE 100 x 10^9 /L
c. Hepatic function as defined by serum bilirubin LE 1.5 x ULN, ALAT and ASAT LE 2.5 x ULN
d. Renal function as defined by serum creatinine LE 1.5 x ULN or creatinine clearance GE 50 ml/min (by Cockcroft-Gault formula).
10. WHO performance status of 0, 1 or 2
11. No radio- or chemotherapy within the last 4 weeks prior to study entry (except for palliative single dose radiotherapy for pain reduction)
12. Able and willing to swallow oral medication;GE = Greater or Equal than
LE = Less or Equal than

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. Unreliable contraceptive methods. 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.
13. Legal incapacity

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to quantitatively determine the<br /><br>pharmacokinetics (absorption, distribution, metabolism and excretion) of<br /><br>docetaxel (as ModraDoc003 10mg tablets) after administration of a single dose<br /><br>of oral docetaxel in combination with ritonavir.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine the presence or absence of quantitatively relevant metabolites<br /><br>of docetaxel.<br /><br>- To elucidate the structures of potential new metabolites of docetaxel<br /><br>- To preliminary assess anti-tumor activity of oral docetaxel combined with<br /><br>ritonavir.<br /><br>- To further characterize the safety and tolerability of oral docetaxel in<br /><br>combination with ritonavir. </p><br>