Trametinib and Hydroxychloroquine in Treating Patients With Pancreatic Cancer (THREAD)
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|ClinicalTrials.gov Identifier: NCT03825289|
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Carcinoma Stage II Pancreatic Cancer Stage IIA Pancreatic Cancer Stage IIB Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer Unresectable Pancreatic Carcinoma||Drug: Hydroxychloroquine Drug: Trametinib||Phase 1|
I. To assess the safety and tolerability of escalating doses of hydroxychloroquine (HCQ) in combination with a fixed dose of trametinib in subjects with metastatic or locally advanced, unresectable pancreatic ductal adenocarcinoma and determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of the combination.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||THREAD: A Phase I Trial of Trametinib and Hydroxychloroquine in Patients With Advanced Pancreatic Cancer|
|Actual Study Start Date :||January 18, 2019|
|Estimated Primary Completion Date :||January 18, 2024|
|Estimated Study Completion Date :||January 18, 2025|
Experimental: Treatment (trametinib, hydroxychloroquine)
Patients receive trametinib PO QD on days 1-28 and hydroxychloroquine PO QD or BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Incidence of adverse events (AEs) [ Time Frame: At 28 days ]To assess the safety and tolerability of escalating doses of hydroxychloroquine (HCQ) in combination with a fixed dose of trametinib in subjects. Adverse events will be collected for each subject that received study treatment.
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): NCT03825289
|Contact: Susan Sharryfirstname.lastname@example.org|
|United States, Utah|
|Huntsman Cancer Institute/University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Conan G. Kinsey 801-585-0255 Conan.Kinsey@hci.utah.edu|
|Principal Investigator: Conan G. Kinsey|
|Principal Investigator:||Conan Kinsey, MD||Huntsman Cancer Institute/ University of Utah|