Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 6:58 AM
Study NCT ID:
NCT05084456
Status:
WITHDRAWN
Last Update Posted:
2021-10-19
First Post:
2019-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Docetaxel in Patients With Normal or Impaired Liver Function
Sponsor:
Modra Pharmaceuticals
Organization:
Study Overview
Official Title:
Weekly Administration of (bi-)Daily Oral Docetaxel in Combination With Ritonavir in Patients With Normal or Impaired Liver Function
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pending further development
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label, single centre pharmacological and safety study to define the safety and pharmacokinetics of ModraDoc006/r in a weekly dosing schedule in patients with impaired liver function who might have benefit from a weekly docetaxel regime. The safety of ModraDoc006 in combination with ritonavir for the patients with mild and moderate impaired liver function will be evaluated with a dose escalation design.
Detailed Description:
Oral administration of (anticancer) drugs has many advantages above intravenously administered compounds for patients. A major obstacle for development of an oral docetaxel formulation is the observed poor bioavailability of the drug after oral administration. This was efficiently improved in several pre-clinical and early clinical studies by co-administration of the CYP3A4 inhibitor ritonavir and by development of a new oral formulation of docetaxel (ModraDoc006).
Currently, treatment with ModraDoc006/r (i.e. oral docetaxel as tablets of 10 mg combined with a ritonavir dose of 100 mg) has been evaluated in several clinical trials at the NKI. In these trials, patients have been treated with ModraDoc006/r for a duration of up to 72 weeks.
Commonly observed toxicities of ModraDoc006/r in the phase I trials were nausea, vomiting, diarrhea and fatigue, mostly being of CTC (Common Toxicity Criteria) grade 1-2 severity and usually not interfering with the therapy. Frequently occurring toxicities of intravenously administered docetaxel, such as neutropenia, hypersensitivity reactions and peripheral polyneuropathy have rarely been observed with ModraDoc006/r.
The established recommended dose for further treatment with ModraDoc006/r is 30mg ModraDoc006 (combined with 100mg ritonavir) in the morning and 20 mg ModraDoc006 (combined with 100 mg ritonavir) in the afternoon, as a bidaily weekly schedule.
Impaired hepatic function The primary goal of this study is to explore the safety and pharmacokinetics of ModraDoc006/r in patients with mild or moderate liver impairment in order to be able to give appropriate and practical dose recommendations in daily clinical practice. According to the recommendations of the EMA and FDA guidelines, the Child-Pugh classification will be used in this study to define different classes of severity of liver impairment. However, patients with Child-Pugh class C score will not be included in the study, because of the expected poor performance status and survival and expected increased toxicity related to severely impaired organ function, for whom the use of ModraDoc006/r is considered contra-indicated.
Patients will receive oral docetaxel (as ModraDoc006 10 mg tablets) and ritonavir (100 mg tablet) once- or bi-daily, once a week in a fasted condition. After the end of the study period of twelve weeks patients will go off study and will immediately be offered the opportunity to embark on the roll over protocol N17DEX. This will ensure fully that the patient will receive ModraDoc006/r in the best interest without limitations.
Currently, treatment with ModraDoc006/r (i.e. oral docetaxel as tablets of 10 mg combined with a ritonavir dose of 100 mg) has been evaluated in several clinical trials at the NKI. In these trials, patients have been treated with ModraDoc006/r for a duration of up to 72 weeks.
Commonly observed toxicities of ModraDoc006/r in the phase I trials were nausea, vomiting, diarrhea and fatigue, mostly being of CTC (Common Toxicity Criteria) grade 1-2 severity and usually not interfering with the therapy. Frequently occurring toxicities of intravenously administered docetaxel, such as neutropenia, hypersensitivity reactions and peripheral polyneuropathy have rarely been observed with ModraDoc006/r.
The established recommended dose for further treatment with ModraDoc006/r is 30mg ModraDoc006 (combined with 100mg ritonavir) in the morning and 20 mg ModraDoc006 (combined with 100 mg ritonavir) in the afternoon, as a bidaily weekly schedule.
Impaired hepatic function The primary goal of this study is to explore the safety and pharmacokinetics of ModraDoc006/r in patients with mild or moderate liver impairment in order to be able to give appropriate and practical dose recommendations in daily clinical practice. According to the recommendations of the EMA and FDA guidelines, the Child-Pugh classification will be used in this study to define different classes of severity of liver impairment. However, patients with Child-Pugh class C score will not be included in the study, because of the expected poor performance status and survival and expected increased toxicity related to severely impaired organ function, for whom the use of ModraDoc006/r is considered contra-indicated.
Patients will receive oral docetaxel (as ModraDoc006 10 mg tablets) and ritonavir (100 mg tablet) once- or bi-daily, once a week in a fasted condition. After the end of the study period of twelve weeks patients will go off study and will immediately be offered the opportunity to embark on the roll over protocol N17DEX. This will ensure fully that the patient will receive ModraDoc006/r in the best interest without limitations.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: