Selumetinib Sulfate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12R Mutations

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03040986
Phase
PHASE2
Status
Completed

Conditions

  • KRAS NP_004976.2:p.G12R
  • Stage III Pancreatic Cancer AJCC v6 and v7
  • Stage IV Pancreatic Cancer AJCC v6 and v7

Eligibility Criteria

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

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Selumetinib Sulfate — DRUG
    Given by mouth (PO)

Study Details

This phase II trial studies how well selumetinib sulfate works in treating patients with pancreatic cancer with Kirsten rat sarcoma (KRAS) G12R mutations that has spread from where it started to nearby tissue or lymph nodes or other places in the body. Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Jul 21, 2017
Status verified
Jan 2021
Primary completion
Aug 10, 2018
Completion
Oct 15, 2020

Study Design

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

Arms

  • Experimental: Treatment (selumetinib sulfate)
    Patients receive selumetinib sulfate by mouth (PO) twice daily (BID). Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity

Primary Outcome Measure

Proportion of Participants With an Objective Response (Partial Response + Complete Response) [ Time Frame: Approximately 1-8.2 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Los Angeles County-USC Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
NCI - Center for Cancer ResearchBethesdaMaryland20892-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Duke University Medical CenterDurhamNorth Carolina27710-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Los Angeles, CA

By research site
Los Angeles County-USC Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUniversity of Kentucky/Markey Cancer Center· Lexington, KYNCI - Center for Cancer Research· Bethesda, MDWayne State University/Karmanos Cancer Institute· Detroit, MI

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