Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04132505|
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : October 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|KRAS Gene Mutation Metastatic Pancreatic Adenocarcinoma Stage IV Pancreatic Cancer AJCC v8||Drug: Binimetinib Drug: Hydroxychloroquine||Phase 1|
I. To determine the maximum tolerated dose of hydroxychloroquine (HCQ) when combined with a fixed dose of binimetinib.
I. To determine the response rate among a pilot cohort of pancreatic cancer patients.
II. To determine the safety and toxicity profile of the combination of binimetinib and HCQ.
III. To determine the ability of the combination to halt tumor growth as measured by progression free survival.
IV. To assess the overall survival of patients treated on this regimen.
I. To compare the efficacy of treatment to somatic gene mutation profile as acquired by standard of care testing.
II. To assess pre- and post- treatment tissue to determine if markers of autophagy correlate with response to treatment.
III. To assess the effect of this binimetinib/HCQ treatment on changes in muscle and fat mass as analyzed by computed tomography (CT) scan (as standard of care treatment).
OUTLINE: This is a dose-escalation study of hydroxychloroquine.
Patients receive binimetinib orally (PO) twice daily (BID) and hydroxychloroquine PO BID on days 1-14. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Binimetinib Plus Hydroxychloroquine in KRAS Mutant Pancreatic Cancer|
|Actual Study Start Date :||October 22, 2019|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 2020|
Experimental: Treatment (binimetinib, hydroxychloroquine)
Patients receive binimetinib PO BID and hydroxychloroquine PO BID on days 1-14. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
- Maximum tolerated dose (MTD) [ Time Frame: Up to 30 days ]Will employ the Bayesian optimal interval (BOIN) design to find the MTD.
- Response rate [ Time Frame: Up to 1 year ]
- Incidence of adverse events [ Time Frame: Up to 1 year ]Toxicity will be assessed using common toxicity criteria version 5.
- Progression free survival [ Time Frame: Up to 1 year ]To determine the ability of the combination to halt tumor growth
- Overall survival [ Time Frame: Up to 1 year ]To assess the overall survival of patients treated on this regimen
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): NCT04132505
|Contact: David R Fogelmanemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: David R. Fogelman 713-792-2828|
|Principal Investigator: David R. Fogelman|
|Principal Investigator:||David R Fogelman||M.D. Anderson Cancer Center|