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NCT02065063 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02065063: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02065063 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02065063, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This is a dose-escalation, Phase I/II, open-label, three-part study. Part 1 is designed to determine the recommended dose and schedule for the orally administered MEK inhibitor trametinib, given together with the CDK4/6 inhibitor palbociclib in subjects with solid tumors. Multiple dose levels of each inhibitor will be tested to determine the recommended dose and schedule. Part 2 will evaluate the effect of the combination on tumor biomarkers safety, and anti-cancer activity in subjects with cutaneous melanoma that do not have a change at BRAFV600. Approximately 100-200 subjects will be enrolled. All subjects will receive trametinib and/or palbociclib until disease progression, death, consent withdrawal or unacceptable adverse event (AE). Data was only collected and analyzed for the Phase I component of the study, the Phase II component of the study was terminated without data collection
Primary Outcome
Vital sign measurements will include systolic and diastolic blood pressure, temperature, respiration rate and pulse rate
Interventions
- DRUG Palbociclib
- DRUG Trametinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-04-22 |
| Est. Completion | 2016-06-23 |
| Phase | Phase 1 |
What the finished NCT02065063 record still lists
NCT02065063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Palbociclib is the first listed.
NCT02065063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02065063 about?
NCT02065063 is a clinical study titled "A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors". This is a dose-escalation, Phase I/II, open-label, three-part study. Part 1 is designed to determine the recommended dose and schedule for the orally administered MEK inhibitor trametinib, given together with the CDK4/6 inhibitor palbociclib in subjects with solid tumors. Multiple dose levels of eac...
What is the current status of trial NCT02065063?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2014-04-22. Estimated completion is 2016-06-23.
What interventions are being tested in trial NCT02065063?
The interventions under investigation include: Palbociclib (DRUG), Trametinib (DRUG).
Who is sponsoring clinical trial NCT02065063?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02065063's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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