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NCT01828034 · ClinicalTrials.gov registry record · Phase 1
First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma
A Phase 1 study of Advanced Biliary Tract Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT01828034: Completed Phase 1 study of Advanced Biliary Tract Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01828034 is a Phase 1 study of Advanced Biliary Tract Carcinoma that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 42 participants, below the 112-participant average among 4 other Advanced Biliary Tract Carcinoma trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01828034, a Phase 1 study of Advanced Biliary Tract Carcinoma, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers. Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and gallbladder cancers. The investigators are looking to improve treatment results. They will attempt to do so by adding the drug MEK162 to the treatment plan. MEK162 acts by blocking a protein called MEK 1/2 which helps cancer cells grow and divide. This study will help answer the question of whether MEK162 is a helpful drug in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.
Primary Outcome
In the phase I portion, up to 18 patients will be enrolled in classic 3+3 cohort dose escalation design to identify the MTD of MEK162 when administered with gemcitabine and cisplatin given weeks 2 and 3 of a 3 week cycle .
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG MEK162
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-04 |
| Est. Completion | 2019-05-30 |
| Phase | Phase 1 |
What the finished NCT01828034 record still lists
NCT01828034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 112-participant average among 4 other Advanced Biliary Tract Carcinoma trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Advanced Biliary Tract Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT01828034 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01828034 about?
NCT01828034 is a clinical study titled "First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma". The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers. Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and gallbladder cancers. The investigators are looking to improve treatment resul...
What is the current status of trial NCT01828034?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2013-04. Estimated completion is 2019-05-30.
What conditions does trial NCT01828034 study?
This clinical trial studies the following conditions: Advanced Biliary Tract Carcinoma.
What interventions are being tested in trial NCT01828034?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), MEK162 (DRUG).
Who is sponsoring clinical trial NCT01828034?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01828034 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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