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NCT01725100 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01725100 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 80 participants.
The verdict
NCT01725100, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This is an open-label, randomized, single-dose, 2-treatment, 2-period, 2-way crossover study with incomplete wash-out in subjects with solid tumors to determine the relative bioavailability of test formulation with lower dimethyl sulfoxide (DMSO) content as compared with standard reference formulation trametinib. Approximately 18 subjects will be randomized to receive either a single dose of Treatment A (standard target DMSO content \[theoretical 11.3%\] formulation of GSK1120212B) or a single dose of Treatment B (lower DMSO Content \[approximately 9.5%\] formulation of GSK1120212B) followed by a 7 day incomplete wash-out period, then a single dose of the other treatment. Administration of the dose under fasted conditions in Periods 1 and 2 will be only on Day 1 followed by 7 days of serial blood sampling for PK analysis of plasma trametinib. Safety assessments, including assessment of AEs, clinical laboratory (hematology and clinical chemistry) and vital signs, will be made throughout the study. After a subject completes the study, he or she may be eligible to enter study MEK114375, an open-label rollover study of trametinib (no wash-out period or follow-up visit required) and continue receiving trametinib. For those subjects who wish to discontinue or complete the current study and choose not enter the rollover study, a follow-up visit should be performed within 21 days after receiving the last dose of study treatment.
Interventions
- DRUG GSK1120212B (Standard DMSO content)
- DRUG GSK1120212B (Lower DMSO content)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-02-05 |
| Est. Completion | 2015-01-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01725100
The ClinicalTrials.gov registry entry for NCT01725100 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GSK1120212B (Standard DMSO content) is the first listed.
NCT01725100 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01725100 about?
NCT01725100 is a clinical study titled "A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies". This is an open-label, randomized, single-dose, 2-treatment, 2-period, 2-way crossover study with incomplete wash-out in subjects with solid tumors to determine the relative bioavailability of test formulation with lower dimethyl sulfoxide (DMSO) content as compared with standard reference formulati...
What is the current status of trial NCT01725100?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2013-02-05. Estimated completion is 2015-01-30.
What interventions are being tested in trial NCT01725100?
The interventions under investigation include: GSK1120212B (Standard DMSO content) (DRUG), GSK1120212B (Lower DMSO content) (DRUG).
Who is sponsoring clinical trial NCT01725100?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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