A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02105350|
Recruitment Status : Withdrawn (Study was never initiated)
First Posted : April 7, 2014
Last Update Posted : February 16, 2018
This is a phase I study (an early study to check the safety of a new drug or drug combination) to find the safest and most tolerated dose of the combination of oxaliplatin with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers and cancers associated with the bile ducts leading from the gallbladder and to and from the liver) that is not curable by surgery and/or has spread beyond the biliary tree (place where cancer started). Everyone will receive the same standard doses of oxaliplatin and gemcitabine but may receive different doses of MEK 162.
MEK 162 is a new drug which plays an important role in the regulation of cell growth and has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. This type of drug has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary cancer.
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Carcinoma Gallbladder Carcinoma||Drug: MEK 162 Drug: Gemcitabine Drug: Oxaliplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of MEK Inhibitor MEK 162 Combined Sequentially With Gemcitabine-Oxaliplatin (GEMOX) in Patients With Advanced Biliary Cancer|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: MEK 162, gemcitabine, and oxaliplatin
MEK 162 (30 mg or 45 mg by mouth), twice a day, every day. Gemcitabine (1000 mg/m2 by vein), followed by oxaliplatin (85 mg/m2 by vein) every 2 weeks.
Drug: MEK 162
Other Name: Gemzar
Other Name: Eloxatin
- Total incidence of grade 3 and 4 adverse events [ Time Frame: 2 years ]
- Total rate of grade 3 and 4 adverse events [ Time Frame: 2 years ]
- Maximum dose level at which 0/3 patients or 1/6 patients experience dose-limiting toxicity [ Time Frame: 2 years ]
- Number of patients with objective response rate [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105350
|Principal Investigator:||Jennifer Knox, M.D.||Princess Margaret Cancer Centre|