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NCT03362723 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT03362723 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 48 participants.
The verdict
NCT03362723, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This multi-center, open-label, pharmacokinetic study will evaluate the bioequivalence (BE) or relative bioavailability (rBA) of three new idasanutlin-tablet variants compared to the reference tablet formulation following oral administration of a 300 milligrams (mg) dose in participants with solid tumors for whom no further treatment options are available. Following the four administrations of idasanutlin in the BE/rBA cycle of the study (Cycle 1), participants who have no clinically defined progressive disease and who recover from any prior treatment toxicity to Grade less than or equal to (\</=) 1 may enter the optional treatment extension phase. This extension phase will continue for additional 28-day cycles or until disease progression or unacceptable toxicity is observed.
Interventions
- DRUG Idasanutlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2019-06-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03362723
The ClinicalTrials.gov registry entry for NCT03362723 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Idasanutlin is the first listed.
NCT03362723 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03362723 about?
NCT03362723 is a clinical study titled "A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors". This multi-center, open-label, pharmacokinetic study will evaluate the bioequivalence (BE) or relative bioavailability (rBA) of three new idasanutlin-tablet variants compared to the reference tablet formulation following oral administration of a 300 milligrams (mg) dose in participants with solid tu...
What is the current status of trial NCT03362723?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2017-11-27. Estimated completion is 2019-06-11.
What interventions are being tested in trial NCT03362723?
The interventions under investigation include: Idasanutlin (DRUG).
Who is sponsoring clinical trial NCT03362723?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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