Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT04132505
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-03
First Post:
2019-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Binimetinib Plus Hydroxychloroquine in KRAS Mutant Metastatic Pancreatic Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the best dose of hydroxychloroquine when given together with binimetinib in treating patients with KRAS gene mutated pancreatic cancer that has spread to other places in the body (metastatic). Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hydroxychloroquine may prevent autophagy, a normal process in which a cell destroys proteins and other substances which may lead to cell death. Autophagy may prevent normal cells from developing into tumor cells, but it may also protect tumor cells by destroying anticancer drugs or substances taken up by them. Giving hydroxychloroquine together with binimetinib may work better in treating patients with pancreatic cancer compared to binimetinib alone.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the maximum tolerated dose of hydroxychloroquine (HCQ) when combined with a fixed dose of binimetinib.
SECONDARY OBJECTIVES:
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.
EXPLORATORY OBJECTIVES:
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.
I. To determine the maximum tolerated dose of hydroxychloroquine (HCQ) when combined with a fixed dose of binimetinib.
SECONDARY OBJECTIVES:
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.
EXPLORATORY OBJECTIVES:
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: