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 : September 9, 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 determine the recommended phase II dose of hydroxychloroquine in combination with trametinib as assessed by the occurrence of dose-limiting toxicities (DLTs).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 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.
- Rate of dose-limiting toxicities during the DLT assessment window. [ Time Frame: At 28 days ]To determine the recommended phase II dose (RP2D) hydroxychloroquine in combination with trametinib.
- Incidence of adverse events (AEs) for the duration of study treatment [ Time Frame: 30 days after last dose ]To assess the safety of the combination of trametinib and hydroxychloroquine
- Response Rate [ Time Frame: 5 years ]To assess the efficacy of the combination of trametinib and hydroxychloroquine
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|