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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Capecitabine
  • DRUG Fluorouracil
  • OTHER Laboratory Biomarker Analysis
  • DRUG Trametinib
  • DRUG Leucovorin Calcium

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2014-02
Est. Completion 2017-04-30
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT02042443

The ClinicalTrials.gov registry entry for NCT02042443 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.

NCT02042443 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.