Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-25 @ 9:39 PM
Study NCT ID:
NCT03150368
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2017-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Use of ModraDoc006/r
Sponsor:
Modra Pharmaceuticals
Organization:
Study Overview
Official Title:
Safety of Extended Use of ModraDoc006/r in Patients With Advanced Solid Tumours
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study for extended use of ModraDoc006/r in patients with advanced solid tumours, available after completed treatment in one of the phase I trials with ModraDoc006/r. The primary goal is to explore the safety of extended use.
Detailed Description:
This is an open label extended use programme, designed to make extended use treatment with weekly ModraDoc006/r available for patients who completed treatment in one of the phase I trials with ModraDoc006/r, who might have clinical benefit of continued treatment with the oral docetaxel formulation.
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. Treatment can be continued weekly as long as the patient experiences clinical benefit from the treatment as judged by the treating oncologist, unless unacceptable toxicity despite dose modifications and supportive measures occurs.
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. Treatment can be continued weekly as long as the patient experiences clinical benefit from the treatment as judged by the treating oncologist, unless unacceptable toxicity despite dose modifications and supportive measures occurs.
Study Oversight
Has Oversight DMC:
False
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?: