Trametinib and Hydroxychloroquine in Treating Patients With Pancreatic Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Utah
Study ID
NCT03825289
Phase
PHASE1
Status
Terminated

Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydroxychloroquine — DRUG
    Given PO
  • Trametinib — DRUG
    Given PO

Study Details

This phase I trial studies the sides effects and best dose of hydroxychloroquine when given together with trametinib in treating patients with pancreatic cancer that has spread to nearby tissue, lymph nodes or other places in the body and cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib together with hydroxychloroquine may work better in treating patients with pancreatic cancer.

Key Dates

Start date
Jan 30, 2019
Status verified
May 2026
Primary completion
Jan 15, 2025
Completion
Aug 3, 2025

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Rate of dose-limiting toxicities during the DLT assessment window. [ Time Frame: At 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

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