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NCT02042443 · ClinicalTrials.gov registry record · Phase 2
Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT02042443: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02042443 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02042443, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving trametinib is more effective than combination chemotherapy in treating patients with biliary or gallbladder cancer.
Primary Outcome
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Interventions
- DRUG Capecitabine
- DRUG Fluorouracil
- OTHER Laboratory Biomarker Analysis
- DRUG Trametinib
- DRUG Leucovorin Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2014-02 |
| Est. Completion | 2017-04-30 |
| Phase | Phase 2 |
What the finished NCT02042443 record still lists
NCT02042443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.
NCT02042443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02042443 about?
NCT02042443 is a clinical study titled "Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery". This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for c...
What is the current status of trial NCT02042443?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2014-02. Estimated completion is 2017-04-30.
What interventions are being tested in trial NCT02042443?
The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Laboratory Biomarker Analysis (OTHER), Trametinib (DRUG), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT02042443?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02042443's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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