First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma
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|ClinicalTrials.gov Identifier: NCT01828034|
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : November 17, 2020
Last Update Posted : November 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Biliary Tract Carcinoma||Drug: Gemcitabine Drug: Cisplatin Drug: MEK162||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 30, 2019|
|Actual Study Completion Date :||May 30, 2019|
Experimental: Gemcitabine, Cisplatin and MEK162
Phase I component of the study, a classic 3+3 cohort dose escalation scheme will be used to identify the MTD of MEK162 when administered with gemcitabine at dose 800 mg/m2 and cisplatin given at dose 20 mg/m2 week 2 & 3 of a 3 week cycle. The final cohort will receive gemcitabine 1000mg/m2 and cisplatin 20mg/m2 week 2 and 3 of a 3 week cycle in combination with MEK162 at the MTD as determined above. In the phase II part of the study, patients will receive MEK162 at the MTD dose plus gemcitabine and cisplatin at the dose level determined acceptable in the phase I portion. In the phase II part of the study, patients will receive MEK162 at 45mg BID plus gemcitabine (800 mg/m2) and cisplatin (20 mg/m2) as determined by the phase I portion.
- MTD of MEK162 - Phase I [ Time Frame: 1 year ]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 .
- Six-month Progression Free Survival [ Time Frame: 6 months ]An exact binomial single stage design will be used to discriminate between true 6-month PFS rates of 59% vs. 82%, and between true response rates of 26% and 50%. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Objective Response Rate (ORR) [ Time Frame: 1 year ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Median PFS [ Time Frame: 1 year ]progression free survival will be calculated from study entry to documented disease progression or death from any cause, whatever occurs first.
- Median Overall Survival [ Time Frame: 1 year ](survival) will be calculated from study entry to death or last follow up
- Participants Evaluated for Toxicity [ Time Frame: 2 years ]All toxicities will be rated as per the NCI Common Toxicity Criteria, version 4.
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): NCT01828034
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Ghassan Abou-Alfa, MD||Memorial Sloan Kettering Cancer Center|