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NCT02705963 · ClinicalTrials.gov registry record · Phase 1
A Drug-Drug Interaction Study to Assess the Effect of Trametinib on the Pharmacokinetics of an Oral Contraceptive in Female Patients With Solid Tumors
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT02705963: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02705963 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02705963, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of trametinib once daily on the pharmacokinetics (PK) of a daily dosing oral contraceptives (OCs) containing norethindrone (NE) and ethinyl estradiol (EE) in female patients with solid tumors. The PK of trametinib and its metabolite M5 will also be assessed.
Primary Outcome
To evaluate the effect of multiple doses of trametinib (2 mg once daily) on the steady state pharmacokinetics of combination OC (NE and EE) in female patients with solid tumors.
Interventions
- DRUG Trametinib
- DRUG Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2016-10-20 |
| Est. Completion | 2019-08-29 |
| Phase | Phase 1 |
What the finished NCT02705963 record still lists
NCT02705963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Trametinib is the first listed.
NCT02705963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02705963 about?
NCT02705963 is a clinical study titled "A Drug-Drug Interaction Study to Assess the Effect of Trametinib on the Pharmacokinetics of an Oral Contraceptive in Female Patients With Solid Tumors". The purpose of this study is to evaluate the effect of trametinib once daily on the pharmacokinetics (PK) of a daily dosing oral contraceptives (OCs) containing norethindrone (NE) and ethinyl estradiol (EE) in female patients with solid tumors. The PK of trametinib and its metabolite M5 will also be...
What is the current status of trial NCT02705963?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2016-10-20. Estimated completion is 2019-08-29.
What interventions are being tested in trial NCT02705963?
The interventions under investigation include: Trametinib (DRUG), Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol) (DRUG).
Who is sponsoring clinical trial NCT02705963?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02705963's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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